Probiotic Solutions Prenatal 20 Billion CFUs by GNC Probiotic Solutions

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Serving Size 2 Capsule(s)

Ingredients	Amount Per Serving
Prenatal Probiotic blend (20 billion active cultures) (Prenatal Probiotic blend Note: 20 billion active cultures )
Lactobacillus rhamnosus GG (Lactobacillus rhamnosus GG )
Bifidobacterium animalis subsp. lactis (Bifidobacterium animalis lactis )

Other Ingredients

Maltodextrin, Vegetarian Capsule Shell (Form: Hydroxypropyl Methylcellulose), Microcrystalline Cellulose, Silicon Dioxide (Alt. Name: SiO2), Magnesium Stearate, Titanium Dioxide

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Below is general information about the effectiveness of the known ingredients contained in the product Probiotic Solutions Prenatal 20 Billion CFUs. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS

POSSIBLY EFFECTIVE

Colic. Oral Bifidobacterium lactis seems to be beneficial for colic. Details: Clinical research in infants with colic shows that taking B. lactis BB-12 (Chr. Hansen, Hoersholm or Bifidolactis Infant, Sofar SpA) drops providing 1 billion colony-forming units (CFUs) daily for 3 or 4 weeks modestly reduces the daily number of crying episodes by about 2.5 when compared with placebo. The proportion of infants with at least a 50% reduction in crying time from baseline was 61% to 80%, compared with 22% to 32% of those taking placebo. Use of B. lactis also resulted in increased sleep time, reduced crying duration, and improved physical and emotional functioning of the caregiver. Stool frequency was decreased in one study, but was not changed in the other (107583,107587).
Constipation. Oral Bifidobacterium lactis seems to be beneficial for constipation. Details: A meta-analysis of clinical research shows that taking B. lactis increases bowel movement frequency by about 1.5 stools weekly in adults with functional constipation. Specific strains used include LMG P-21384 as 5 billion colony-forming units (CFUs) daily, Bi-07 as 100 million CFUs daily, DN-173 010 as 12.5 billion CFUs daily, and GCL2505 as 10 billion CFUs daily for 2-4 weeks (95342). Another meta-analysis of clinical research in adults with chronic constipation shows that taking B. lactis modestly increases stool frequency when compared with taking placebo. However, there was no effect of taking B. lactis on treatment success, stool consistency, severity of straining or bloating, or gut transit time. Due to the small number of studies, the effect of B. lactis on other symptoms of constipation is unclear from this analysis (110874). A third meta-analysis shows that two specific strains of B. lactis, HN019 and DN-173 010, have medium to large effects on intestinal transit time in mainly healthy adults (110983). The effect of these strains on intestinal transit time in patients with constipation is unclear from this analysis. Clinical research in patients with low defecation frequency also shows that taking the specific B. lactis strain BB-12 (Chr. Hansen A/S) 1-10 billion CFUs daily for 4 weeks increases the odds of improved defecation frequency by about 1.3-fold when compared with placebo (92264). It is possible that any beneficial effect is limited to patients with more severe constipation. One clinical study in patients with functional constipation shows that taking the specific B. lactis strain HN019, 1 or 10 billion CFUs daily for 4 weeks, has no effect on bowel movements when compared with placebo. However, in a post-hoc analysis of patients with three or less weekly stools, this strain of B. lactis modestly increased bowel movements when compared with placebo (98737). Another clinical study in patients with mild chronic constipation shows that taking B. lactis NCC2818 15 billion CFUs daily for 4 weeks does not affect gut transit time, stool output, or symptoms when compared with placebo (102411). B. lactis has also been examined in combination with other ingredients. One small clinical trial using a specific combination product (ID-HWS1000) containing B. lactis IDCC 4301, Bifidobacterium breve IDCC 4401, Lacticaseibacillus casei IDCC 3451, Lactiplantibacillus plantarum IDCC 3501, Lacticaseibacillus rhamnosus IDCC 3201, Lactococcus lactis IDCC 2301, xylooligosaccharide, and dietary fiber as nondigestible maltodextrin, oat fiber, and psyllium husk fiber daily for 4 weeks modestly increases stool frequency and improves symptoms of functional constipation in adults when compared with placebo (107517). Another small clinical trial shows that taking yogurt 180 mL providing B. lactis HN019, L. acidophilus NCFM, and polydextrose (Litesse) daily for 2 weeks modestly improves clinical response and reduces transit time when compared with taking a control yogurt. However, there was no effect on the number of daily bowel movements (90275). Other studies have used B. lactis UABla-12, Bl-04, Bi-07, and/or HN019 in combination with Bifidobacterium bifidum UABb-10, Bifidobacterium longum UABl-14, Lactobacillus acidophilus DDS-1, and fructo-oligosaccharides (FOS) for 4 weeks (110970) or Lactobacillus acidophilus NCFM and Lacticaseibacillus paracasei Lpc-37 for 2 weeks (110979). However, there was a general lack of support for symptom improvement from these studies.
Irritable bowel syndrome (IBS). Oral Bifidobacterium lactis seems to be beneficial for reducing symptoms of IBS when used alone. Its benefits when used in combination with other probiotics are unclear. Details: Clinical research in adults with IBS shows that taking B. lactis UABla-12 10 billion colony-forming units (CFUs) daily for 6 weeks modestly reduces the severity of abdominal pain when compared with placebo. Also, 28% of patients responded to treatment by having more than a 30% reduction in pain severity, compared with only 16% of those taking placebo. There were also improvements in abdominal distention, duration of pain, and bowel habits (107581). Additional clinical research in children aged 4-16 years shows that taking B. lactis B19 10 billion CFUs daily for 4 weeks reduces bloating, feelings of abdominal fullness, and difficulty with defecation in 25% to 50% of patients with IBS (95350). Some research has also evaluated B. lactis in combination with other probiotics. Clinical research shows that taking a product (Duolac Care) containing B. lactis, Bifidobacterium breve, Lactobacillus acidophilus, Lactiplantibacillus plantarum, Lacticaseibacillus rhamnosus, and Streptococcus thermophilus twice daily for 4 weeks can relieve symptoms in 72% of patients with IBS (95353). Another clinical study in patients with diarrhea-predominant IBS shows that taking a specific multi-species probiotic (NordBiotic, MBM Biotix) containing B. lactis BL040, B. breve BB010, Bifidobacterium longum BL020, Bifidobacterium bifidum BF030, Lacticaseibacillus rhamnosus LR110, Lacticaseibacillus paracasei LPC100, L. acidophilus LA120, Lacticaseibacillus casei LC130, L. plantarum LP140, and Streptococcus thermophilus ST250 as 2.5 billion CFUs total twice daily for 8 weeks improves overall symptom severity, as well as pain severity, pain frequency, and quality of life when compared with placebo. Symptom severity was rated as mild by approximately 60% of those taking the probiotic mixture, compared with 30% of those taking placebo (107516). However, multiple studies show that taking capsules or drinking fermented milk containing a combination of B. lactis BB-12, L. paracasei, and L. acidophilus La510 as 26 billion CFUs total twice daily for 2-6 months does not improve gastrointestinal symptoms in patients with IBS (90236,94696,94697).
Respiratory tract infections. Most clinical research shows that taking Bifidobacterium lactis alone or in combination with other probiotics may reduce the risk of respiratory infections in otherwise healthy individuals. In patients who are not otherwise healthy, most clinical research shows that taking oral B. lactis has not demonstrated benefit. Details: Clinical research in infants aged 6 to 12 months shows that taking B. lactis HN019 one million colony-forming units (CFUs) per gram of follow-on formula daily for 12 weeks reduces the incidence of confirmed (9.4% vs. 0.0%) and parentally reported (25.0% vs. 9.4%) upper respiratory tract infections when compared to formula without added probiotics. Infants consumed an average of 141 grams of formula daily (110988). Another clinical trial in one month old infants shows that taking B. lactis BB-12 10 billion CFUs daily for an average of about 15 months reduces the proportion of children with respiratory tract infections until age 2 by 13% when compared with taking placebo. The frequency of recurrent respiratory tract infections was not different between groups (95381). In contrast, other clinical research in children attending day care shows that taking B. lactis BB-12 one billion CFUs daily for 3 months does not reduce the duration or incidence of respiratory tract infections (95382). Most research in children also shows that taking B. lactis in combination with other ingredients reduces the risk of respiratory infections. One clinical study shows that children ages 3-5 years who attend day-care centers have significantly fewer influenza-like respiratory symptoms when given milk containing a specific combination of 5 billion CFUs each of B. lactis and Lactobacillus acidophilus (HOWARU Protect, Danisco). Children taking this product seem to have a 45% lower risk of experiencing fever, cough, and rhinorrhea when compared with placebo. The duration of symptoms was also 2 days shorter. These patients were also less likely to use an antibiotic for their symptoms (16847). A clinical study in healthy children aged 3-10 years shows that taking 12.5 billion CFUs daily of a specific combination of B. lactis CUL34 (Lab4), Bifidobacterium bifidum CUL20, and L. acidophilus CUL21 and CUL60, plus vitamin C 50 mg daily reduces the risk of cough by 16% and sore throat by 20% and modestly reduces school absenteeism and antibiotic use when compared with placebo. However, nasal symptoms, fever, and wheezing were not reduced (106943). Another clinical study in children 3-12 years of age with a sick household member shows that taking a combination product (Up4-Junior, UAS Laboratories) containing B. lactis UABLA-12 4 billion CFUs and L. acidophilus DDS-1 1 billion CFUs with fructo-oligosaccharides 50 mg daily for 2 weeks modestly shortens the duration of respiratory infections, but does not reduce the risk of developing an infection, when compared with placebo (98439). In healthy children ages 3-6 years, taking a combination of B. lactis BB-12 and Enterococcus faecium L3 (iNatal Ped, Pharmextracta SpA) 2 billion CFUs each daily for 3 months reduces the incidence of upper respiratory tract infections by 84% compared with children not taking probiotics. The duration of infections was reduced by 50% (110991). The effect of B. lactis on respiratory tract infections has also been examined in adults. In healthy overweight adults or adults with obesity, taking 50 billion CFUs of a specific combination of B. lactis (Lab4P), B. bifidum, L. acidophilus, and Lactiplantibacillus plantarum for 24 weeks reduces the overall likelihood of having upper respiratory tract infection symptoms, such as sneezing, cough, and blocked nose, by approximately 40% when compared with placebo (103439). In college students, clinical research shows that taking B. lactis BB-12 and Lacticaseibacillus rhamnosus LGG one billion CFUs each daily for 12 weeks reduces the duration of upper respiratory tract infection by about 2 days when compared with placebo. Symptom severity was reduced by 34%. There was also a small reduction in the number of missed school days, but not work days (110993). Some research has investigated the effects of B. lactis on respiratory tract infection outcomes in patients who are not otherwise healthy. One clinical trial in children hospitalized with an acute respiratory tract infection shows that taking B. lactis Probio-M8 20 billion CFUs daily from admission until 4 weeks after discharge modestly reduces the duration of nasal, throat, and general aching symptoms when compared with taking placebo. Taking B. lactis also modestly reduced the proportion of patients requiring hospitalization of at least 7 days (110984). Despite these findings, another clinical trial in children and adolescents who are hospitalized shows that taking B. lactis 100 million CFUs daily during a hospital stay does not reduce the incidence or duration of respiratory infections, including common cold, rhinitis, sinusitis, and others, when compared with placebo (92265). Also, in older adults in long-term care, taking a combination of B. lactis BB-12 and Lacticaseibacillus rhamnosus 13-16 billion CFUs daily does not reduce the incidence of upper or lower respiratory infections when compared with placebo over a 12-month period, and increases the use of antibiotics for lower respiratory tract infections by 2.2 days (103425).

POSSIBLY INEFFECTIVE

Dental caries. Oral Bifidobacterium lactis does not seem to be beneficial for preventing dental caries in young children. Details: Clinical research in infants shows that giving B. lactis BB-12 DSM 15954 (Chr. Hansen A/S) 5 billion colony-forming units (CFUs) daily, starting at age 1-2 months and continuing for an average of 15 months, through a sustained-release pacifier or tablet does not reduce the incidence of dental caries at age 4 when compared with placebo (107588).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Allergic rhinitis (hay fever). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children aged 6-17 years with allergic rhinitis shows that taking a specific combination product (Inatal ped Pharmaextracta) containing B. lactis BB-12 DSM 15954 and Enterococcus faecium L3 LMG P-27496 2 billion colony-forming units (CFUs) each with oligofructose daily for 3 months prior to a high allergen exposure period the period modestly reduces symptoms of allergic rhinitis and the need for corticosteroids and/or oral antihistamines when compared with baseline (107582). However, other clinical research shows that drinking 250 mL of fermented milk containing B. lactis BB-12 50 billion CFUs, Lacticaseibacillus rhamnosus GG 50 billion CFUs, and Lactobacillus acidophilus La-5 5 billion CFUs from 36 weeks' gestation until 3 months postpartum does not reduce the incidence of allergic rhinitis in the child at 6 years of age when compared with placebo milk (96893).
Antibiotic-associated diarrhea. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of 6 clinical trials in hospitalized or outpatient adults shows that taking B. lactis in combination with up to 8 other probiotic strains reduces the risk of antibiotic-associated diarrhea by 30% when compared with taking placebo (107635). However, individual clinical trials have mixed results. Some specific combination products containing B. bifidum have shown benefit for antibiotic-associated diarrhea (AAD). One such product is Ecologic AAD, which contains B. lactis NIZO 3680, Bifidobacterium bifidum NIZO 3804, Enterococcus faecium NIZO 3886, L. acidophilus NIZO 3678 and NIZO 3887, Lacticaseibacillus paracasei NIZO 3672, Lactiplantibacillus plantarum NIZO 3684, Lacticaseibacillus rhamnosus NIZO 3689, and Ligilactobacillus salivarius NIZO 3675. Another evaluated product contains B. lactis BB-12 5.9 billion CFUs daily, L. rhamnosus GG 5.2 billion CFUs, and L. acidophilus La-5 8.3 billion CFUs daily. However, other combinations do not appear to be beneficial. These include B. lactis BB-12 and L. acidophilus LA-5; B. lactis BB-12 and L. rhamnosus; B. lactis, B. bifidum, and L. acidophilus; and B. lactis W51, B. bifidum W23, L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L. rhamnosus W71, and L. salivarius W24 (90239,92255,94692,95348,95405,103425,110969). It is too soon to know which combinations might be most beneficial, if any, for preventing AAD.
Atopic dermatitis (eczema). It is unclear if oral Bifidobacterium lactis is beneficial for the prevention or treatment of atopic dermatitis. Details: Some research has evaluated B. lactis for TREATING atopic dermatitis. One very small clinical study shows that giving infants a formula containing B. lactis BB-12 (Chr. Hansen A/S) 30-80 billion colony-forming units (CFUs) daily helps reduce the severity of eczema and the markers for allergic responses, including soluble CD4 in serum and eosinophilic protein X in urine when compared with baseline (3458). However, preliminary clinical research shows that giving B. lactis CNCM I-3446 10 billion CFUs to infants as an adjunct to standard topical treatment daily for 3 months does not reduce eczema severity when compared with placebo (90256). B. lactis has also been investigated in combination with other ingredients. In children, taking B. lactis as part of a multi-ingredient formulation for 8 or 12 weeks modestly reduces symptom severity and the need for topical corticosteroids when compared with placebo (107531,110995). In these studies, 1 billion CFUs of a 1:1:1 combination of B. lactis CECT 8145, Lacticaseibacillus casei CECT 9104, and Bifidobacterium longum CECT 7347 daily was used in children ages 4-17 years for 12 weeks (107531) or B. lactis UABLA-12 was taken in combination with Lactobacillus acidophilus DDS-1 for a total of 10 billion CFUs daily along with fructo-oligosaccharide 100 mg (DDS Junior) daily for 8 weeks by children ages 1-3 years (110995). B. lactis-containing probiotics have also been investigated for PREVENTING atopic dermatitis. A meta-analysis of small- to medium-sized studies shows that providing mixed strains of lactobacilli and bifidobacteria to infants during pregnancy and/or in early infancy prevents atopic dermatitis in the child by approximately 40% over the next 0.5-2 years (107503). Although this analysis was not limited to studies examining the effects of B. lactis, seven of the nine studies used B. lactis as part of a combination product. Individual studies included in the analysis have shown that taking a combination of B. lactis, Bifidobacterium bifidum, Ligilactobacillus salivarius, and Lacticaseibacillus paracasei during pregnancy from approximately 35 weeks' gestation until birth, and then giving this combination to the infant after birth until 6 months of age, does not reduce the incidence of eczema at age 2 years, although it does appear to reduce the risk of atopic sensitization by 57% (90234). A secondary analysis of a clinical study included in this analysis in infants aged 8-14 months found that taking a daily mixture of B. lactis and Lacticaseibacillus rhamnosus 1 billion CFUs each daily for 6 months is associated with a lower incidence of eczema when compared with placebo (102286). Also, some clinical research shows that supplementation with 250 mL of fermented milk containing B. lactis BB-12, Lacticaseibacillus rhamnosus GG, and Lactobacillus acidophilus La-5 starting at 36 weeks' gestation and continuing until 3 months postpartum, without supplementation in the infant, reduces the overall occurrence of atopic dermatitis in the child at 2 years of age. At 6 years of age, the effect appears to be inconclusive (96893).
Bipolar disorder. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with bipolar disorder who were recently hospitalized for a manic episode shows that taking a combination probiotic containing B. lactis BB-12 and Lacticaseibacillus rhamnosus GG 100 million colony-forming units daily for 24 weeks reduces the risk of rehospitalization when compared with placebo. The hazard ratio for the first rehospitalization due to worsening of psychiatric symptoms was 0.37 for the combination probiotic group when compared with placebo. Among patients who were re-hospitalized, taking the combination probiotic reduced the mean duration of rehospitalization by 5.4 days when compared with placebo (96896).
Cancer. Although there has been interest in using oral Bifidobacterium lactis for cancer prevention or treatment, there is insufficient reliable information about the clinical effects of B. lactis for this condition.
Canker sores. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small study shows that taking a combination of B. lactis, Lacticaseibacillus paracasei, Lacticaseibacillus rhamnosus, and Lactobacillus acidophilus reduces pain, but does not affect the number of lesions or healing time, when compared with placebo. Also, another small study shows that using lozenges providing inulin 0.13 gram along with B. lactis and L. acidophilus 1.5 billion colony-forming units each reduces pain, but does not affect ulcer size or healing, when compared with Oracure gel (105146).
Child development. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An 11-year follow-up study evaluating B. lactis and Lacticaseibacillus rhamnosus taken daily during pregnancy from 35 weeks' gestation until birth, or six months after birth if breastfeeding, and then giving the same supplement to the infant until 2 years of age, does not affect neurocognitive outcomes such as attention, intelligence, executive function, depression, and anxiety when compared with those taking placebo (102287).
Clostridioides difficile infection. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large clinical study in inpatients aged 65 years or older shows that taking a combination of B. lactis, Bifidobacterium bifidium, and Lactobacillus acidophilus 60 billion colony-forming units daily for 21 days does not reduce the incidence of C. difficile diarrhea when compared with placebo (92255). Other combinations also do not appear to be beneficial, including a combination of B. lactis Bi-04, B. lactis Bi-07, Lactobacillus acidophilus, and Lacticaseibacillus paracasei, as well as a combination of B. lactis Bb-12, Lacticaseibacillus rhamnosus GG, and L. acidophilus La-5 (95364).
Critical illness (trauma). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in multi-trauma patients requiring ventilation shows that taking a combination probiotic containing B. lactis twice daily for 15 days modestly reduces the risk of sepsis, as well as the length of stay in the ICU and hospital, when compared with placebo. The product contained B. lactis BB12 1.75 billion colony-forming units (CFUs) in combination with Lactobacillus acidophilus LA-5 1.75 billion CFUs, Lactiplantibacillus plantarum 500 million CFUs, and Saccharomyces boulardii 1.5 billion CFUs. Half of the dose was given onto the oropharynx and half via a nasogastric tube (107524).
Dental plaque. It is unclear if Bifidobacterium lactis is beneficial for preventing dental plaque. Details: Preliminary clinical research shows that consuming a yogurt supplemented with B. lactis DN-173010 100 million colony-forming units daily between breakfast and lunch for 4 weeks does not prevent gingivitis or plaque when compared with a placebo yogurt. However, following a non-brushing period of 5 days, both gingivitis and plaque were modestly reduced in individuals consuming the B. lactis-containing yogurt (98502). Clinical research in adolescent boys aged 13-15 years with mild to moderate gingival inflammation shows that taking two lozenges containing B. lactis BB-12 (Chr. Hansen A/S) and Lacticaseibacillus rhamnosus GG (Probiotical SpA) twice daily for 4 weeks does not reduce plaque when compared with placebo. However, there was a benefit on levels of some salivary and plaque pathogenic bacteria. Each lozenge provided B. lactis BB-12 470 million colony-forming units (CFUs) and L. rhamnosus 440 million CFUs (107574). Conversely, a small clinical trial in healthy adults shows that taking four lozenges daily providing a total daily dose of 2 billion CFUs each of B. lactis BB-12 DSM 15954 (Chr. Hansen A/S) and L. rhamnosus GG ATCC 53103 (Probiotical SpA) for 4 weeks modestly reduces plaque when compared with placebo (107572).
Diabetes. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of four clinical trials shows that taking probiotics during pregnancy is unlikely to prevent gestational diabetes and increases the risk of pre-eclampsia by 85% when compared with placebo. Although the specific effects of B. lactis are unclear from this analysis, three of the included studies used B. lactis in combination with Lacticaseibacillus rhamnosus (105185). Other clinical research that has found no benefit has used B. lactis BB-12 and L. rhamnosus GG at least 1 billion CFUs daily from 16-20 weeks' gestation until 28 weeks' gestation, or B. lactis 420 DSM 22089 (Dupont Nutrition & Health) and L. rhamnosus HN001 ATCC SD5675 as 10 billion CFUs each daily throughout pregnancy, with or without fish oil (102284,105144). Conversely, one small clinical study in adults with gestational diabetes shows that taking a combination of B. lactis BB-12, Streptococcus thermophilus STY-31, Lactobacillus acidophilus LA-5, and Lactobacillus delbrueckii subsp. bulgaricus LBY-27 for 8 weeks, starting at 24-28 weeks' gestation, modestly reduces fasting blood glucose and improves insulin sensitively when compared with placebo (96892). In children aged 8-17 years with type I diabetes, taking B. lactis Bb12 DSM 15954 and L. rhamnosus GG ATCC 53103 1 billion CFUs daily for 6 months does not reduce insulin requirements or levels of glycated hemoglobin over 12 months when compared with placebo. In addition, C-peptide levels and the maintenance of residual pancreatic beta-cell function were not affected (107518). A small clinical trial in adults with type 2 diabetes shows that taking fermented goat milk 120 grams containing one billion colony-forming units each of B. lactis BB-12 and Lactobacillus acidophilus La-5 daily for 6 weeks modestly reduces levels of glycated hemoglobin and low-density lipoprotein (LDL) cholesterol, but not fasting blood glucose or insulin resistance, when compared with conventional fermented milk containing Streptococcus thermophilus TA-40 (110973).
Diarrhea. It is unclear if oral Bifidobacterium lactis is beneficial for the treatment or prevention of diarrhea. Details: The European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388). However, B. lactis is not a specific focus of the guidelines and most evidence is low quality. Clinical research shows that B. lactis reduces the duration of acute diarrhea in children by about one day (107636). In older adults in long-term care, clinical research shows that taking a combination of B. lactis BB-12 and Lacticaseibacillus rhamnosus 13-16 billion colony-forming units daily does not reduce the incidence or duration of diarrhea over a 12-month period when compared with placebo (103425).
Familial hypercholesterolemia. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children 6-18 years of age with high cholesterol shows that taking a probiotic containing B. lactis MB 2409, Bifidobacterium bifidum MB 109, and Bifidobacterium longum BL04 daily for 12 weeks decreases total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride levels by 2% to 3% and increases HDL cholesterol levels by about 2% when compared with placebo. However, these changes might not be considered clinically significant (98736).
Generalized anxiety disorder (GAD). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in patients newly diagnosed with GAD shows that taking sertraline 25 mg plus probiotics daily for 8 weeks may modestly reduce some symptoms of anxiety when compared with sertraline alone. However, the reduction in anxiety score was small and change was not consistent between rating scales. Also, the quality of life was not improved. The probiotics provided a total of 18 billion colony-forming units of B. lactis, Bifidobacterium longum, Bifidobacterium bifidum, and Lactobacillus acidophilus (110977).
Gingivitis. It is unclear if oral Bifidobacterium lactis is beneficial for gingivitis. Details: Preliminary clinical research shows that consuming a yogurt supplemented with B. lactis DN-173010 100 million colony-forming units (CFUs) daily between breakfast and lunch for 4 weeks does not prevent gingivitis or plaque when compared with a placebo yogurt. However, following a non-brushing period of 5 days, both gingivitis and plaque were modestly reduced in individuals consuming the B. lactis-containing yogurt (98502). Another clinical trial following cleaning in patients with gingivitis shows that taking lozenges containing B. lactis HN019 (HOWARU Bifdo LYO 40 DCU-S, Danisco) one billion CFUs twice daily for 8 weeks increases the proportion of patients without generalized gingivitis by almost 50%, and modestly reduces bleeding with probing and gingivitis severity, compared with placebo lozenges. There was no effect on plaque (110992). B. lactis has also been investigated in combination with other ingredients. Clinical research in adolescent boys aged 13-15 years with mild to moderate gingival inflammation shows that taking two lozenges containing B. lactis BB-12 (Chr. Hansen A/S) and Lacticaseibacillus rhamnosus GG (Probiotical SpA) twice daily for 4 weeks modestly reduces gingivitis when compared with placebo. Each lozenge provided B. lactis BB-12 480 million colony-forming units (CFUs) and L. rhamnosus 440 million CFUs (107574). A small clinical trial in healthy adults shows that taking four lozenges daily providing a total daily dose of 2 billion CFUs each of B. lactis BB-12 DSM 15954 (Chr. Hansen A/S) and L. rhamnosus GG ATCC 53103 (Probiotical SpA) for 4 weeks modestly reduces plaque and gingivitis when compared with placebo (107572).
Helicobacter pylori. It is unclear if oral Bifidobacterium lactis is beneficial for H. pylori; some research suggests that B. lactis may minimize the adverse effects of H. pylori eradication therapy, but not all research agrees. Details: Preliminary clinical research shows that adding B. lactis B94 7 billion colony-forming units (CFUs) daily to sequential H. pylori eradication therapy for 2 weeks results in an eradication rate of 87%, compared with 71% of those taking placebo or using no control along with sequential eradication therapy. Use of B. lactis also reduced treatment non-compliance due to diarrhea during the first week and reduced symptoms such as loss of appetite, nausea, and abdominal pain. In order to have one beneficial outcome, 6.2 patients would need to take B. lactis. There was no overall effect on non-compliance related to diarrhea or to skin rash (107589). Another clinical study shows that taking a specific combination of B. lactis and a lactobacilli species (Ferzym, Specchiasol) 5 billion CFUs daily for one week during standard triple therapy and one week thereafter reduces some treatment-related adverse effects such as taste disturbances and diarrhea, although it does not seem to improve compliance (12763). However, there was no difference in eradication rates or symptom relief in children aged 6-16 years taking B. lactis B94 5 billion CFUs daily plus inulin 900 mg for 14 days along with standard triple therapy (107590). Discrepancies may be related to the population studied or to the B. lactis strain, the other ingredients, or the type of H. pylori treatment used in the available research.
Hypercholesterolemia. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of nine small to moderate-sized clinical studies shows that taking a combination of B. lactis and Lactobacillus acidophilus reduces levels of total cholesterol when compared with placebo (107591). Populations in the included clinical trials enrolled patients with hypercholesterolemia, type 2 diabetes, nonalcoholic fatty liver disease (NAFLD), metabolic syndrome, and others. The benefits of B. lactis in patients with hypercholesterolemia are unclear.
Inflammatory bowel disease (IBD). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial shows that taking 10 billion colony-forming units each of B. lactis BB-12 and Lactobacillus acidophilus LA-5 twice daily for 12 weeks does not increase the proportion of patients with a reduction in weekly bowel frequency of at least 50% when compared with placebo. Also, there was no effect of this combination on stool consistency or abdominal symptoms. However, there were some modest benefits when compared with baseline (110999). This study was small and may have been underpowered to detect differences.
Malnourishment-related diarrhea. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children aged 6 months to 4 years of age hospitalized with severe acute malnutrition shows that taking B. lactis BB-12 and Lacticaseibacillus rhamnosus LGG 5 billion colony-forming units each daily during hospitalization and for 8-12 weeks as an outpatient does not affect diarrhea incidence or severity or the number of days with diarrhea during hospitalization. However, the number of days with diarrhea as an outpatient was reduced by 2.2 days (110996).
Malnutrition. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children aged 6 months to 4 years of age hospitalized with severe acute malnutrition shows that taking B. lactis BB-12 and Lacticaseibacillus rhamnosus LGG 5 billion colony-forming units each daily during hospitalization and for 8-12 weeks as an outpatient does not affect pneumonia incidence, duration, or severity, weight gain, duration of hospitalization, or other outcomes (110996).
Metabolic syndrome. It is unclear if oral Bifidobacterium lactis is beneficial for metabolic syndrome. Details: In patients with metabolic syndrome, preliminary clinical research shows that taking fermented milk 80 mL providing B. lactis HN019 27.2 billion colony-forming units daily for 45 days reduces body mass index by approximately 4% and low-density lipoprotein (LDL) cholesterol by approximately 14% when compared with no treatment. There was no effect on waist circumference, glucose control, or other blood lipids (105154).
Necrotizing enterocolitis (NEC). It is unclear if oral Bifidobacterium lactis is beneficial or safe for NEC prevention. Details: Meta-analyses of clinical research generally show that giving various bifidobacteria species alone does NOT reduce the risk of NEC or all-cause mortality. However, only a few of the studies included in these analyses have used B. lactis (95344,95351,103437,105164). A systematic review of four studies using B. lactis shows that although NEC incidence is reduced by 89% in one study, a significant reduction was not identified in the other studies when compared with placebo (107592). A network meta-analysis of two clinical studies shows that taking a combination probiotic containing B. lactis Bb-12, Bifidobacterium longum subsp. infantis Bb-02, and Streptococcus thermophilus TH-4, reduces the risk of NEC by 71% when compared with control (102437). Despite these findings, guidance among regulatory agencies and clinical organizations varies with respect to the use of probiotics in very low birth weight infants under 1000 grams. The US Food and Drug Administration (FDA) warns that preterm infants given probiotics are at risk of serious infections caused by the bacteria or fungi contained in probiotics due to cases reported in this group of infants (111610). Also, The American Academy of Pediatrics does not support the routine administration of probiotics to preterm infants, particularly those with a birth weight below 1000 grams, due to conflicting data on safety and efficacy and potential for harm in this vulnerable population (111608). The Canadian Paediatric Society, the American Gastroenterological Association, and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition state that probiotic combinations may be of benefit in reducing the incidence of NEC in preterm neonates over 1000 grams. However, B. lactis is not specifically recommended (103003,111609,111611).
Neonatal jaundice. It is unclear if oral Bifidobacterium lactis is beneficial for neonatal jaundice. Details: Clinical research in newborns with jaundice shows that taking B. lactis CP-9 5 billion colony-forming units twice daily during conventional phototherapy treatment reduces the duration of phototherapy by about 13 hours and modestly improves the decline in serum bilirubin when compared with taking placebo. A sub-analysis shows that this benefit is limited to full-term, and not preterm, newborns (110987).
Nonalcoholic fatty liver disease (NAFLD). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In children with NAFLD, clinical research shows that taking a specific combination (Prokid, Gostaresh Milad Pouya Company) containing B. lactis DSMZ 32269 6 billion colony-forming units (CFUs), Lactobacillus acidophilus ATCC B3208 3 billion CFUs, Lacticaseibacillus rhamnosus DSMZ 21690 2 billion CFUs, and Bifidobacterium bifidum ATCC SD6576 2 billion CFUs daily for 12 weeks normalizes liver sonography findings in 53% of children, compared with 17% of those taking placebo. In addition, levels of alanine aminotransferase and aspartate aminotransferase are reduced by 30% and 25%, respectively. There was no effect on body mass index or blood lipids when compared with placebo (105156). However, other research in adults with NAFLD shows that taking probiotic yogurt 100 grams fortified with vitamin D 1000 IU plus B. lactis Bb-12 and L. acidophilus 40 million CFUs daily for 3 months does not improve fasting blood glucose levels, insulin levels, blood pressure, or anthropometric indices when compared with unfortified yogurt (105174).
Obesity. It is unclear if oral Bifidobacterium lactis is beneficial for weight loss. Details: Clinical research in overweight and obese adults shows that taking B. lactis 420 10 billion colony-forming units (CFUs) daily for 6 months does not reduce body fat or body weight when compared with placebo (95356). However, in individuals with abdominal obesity, clinical research shows that taking B. lactis CECT 8145 (Ba8145) 10 billion CFUs for 3 months modestly decreases body mass index (BMI) when compared with placebo. Also, taking heat-killed B. lactis CECT 8145 (Ba8145) 10 billion CFUs modestly decreases waist circumference when compared with placebo. Sub-group analyses show that these benefits occur only in females, and there was no effect of these products on the visceral or subcutaneous fat areas when compared with placebo (105551). Another clinical trial shows that taking 10 billion colony-forming units each of B. lactis 420 and Lacticaseibacillus rhamnosus HN001 daily, alone and with fish oil providing eicosapentaenoic acid 0.22 grams and docosahexaenoic acid 1.9 grams (Croda Europe Ltd.), during pregnancy and for 6 months postpartum, reduces the odds of overweight at 24 months by approximately 64% or 78%, respectively, when compared with taking placebo (110336). When taken in combination with Lactobacillus acidophilus LA02, B. lactis BS01 2 billion CFUs daily for 6 weeks does not reduce body weight or body fat when compared with placebo in young, healthy individuals, only some of whom were overweight (103438). In contrast to these findings, clinical research shows that taking 50 billion CFUs of a specific combination of B. lactis, Bifidobacterium bifidum, L. acidophilus, and Lactiplantibacillus plantarum (Lab4P) for 24 weeks reduces body weight by an additional 1.3 kg more than placebo (103439). Heat-killed B. lactis has also been investigated in combination with other ingredientd. Clinical research shows that taking enriched seafood sticks 50 grams daily providing heat-inactivated B. lactis CECT 8145 5 billion colony-forming units, inulin 1.7 grams, and eicosapentaenoic acid plus docosahexaenoic acid 370 mg daily for 12 weeks does not reduce body weight, body fat, blood pressure, or most lipid or glycemic indices, when compared to taking conventional seafood sticks. There was a modest decrease in insulin levels in males (110997).
Oropharyngeal candidiasis. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In older adults in long-term care, clinical research shows that taking a combination of B. lactis BB-12 and Lacticaseibacillus rhamnosus 13-16 billion colony-forming units daily does not reduce the incidence of oropharyngeal candidiasis when compared with placebo over a 12-month period (103425).
Otitis media. It is unclear if oral Bifidobacterium lactis is beneficial for preventing otitis media. Details: Clinical research in one month old infants shows that taking B. lactis BB-12 10 billion colony-forming units daily for an average of about 15 months does not reduce the proportion of children with otitis media by two years of age when compared with taking placebo (95381).
Periodontitis. It is unclear if oral Bifidobacterium lactis is beneficial for periodontitis. Details: In patients with periodontitis, a small clinical trial shows that taking B. lactis HN019 lozenges providing 1 billion colony-forming units twice daily (HOWARU1 Bifido LYO 40 DCU-S, DuPont Danisco Sweeteners Oy) for 30 days after scaling and root planing modestly improves some measures of periodontitis 60 days after treatment completion, including pocket depth and clinical attachment, when compared with using placebo lozenges. In addition, although the risk for disease progression was not improved when compared with placebo, there was a reduction in the need for additional therapy in at least three sites (105157,105158,107622).
Postoperative bowel function. It is unclear if oral Bifidobacterium lactis is beneficial for improving postoperative bowel function. Details: Clinical research in patients undergoing colorectal polyp resection shows that taking B. lactis MH-02 2 billion colony-forming units daily for 7 days postoperatively does not reduce total postoperative gastrointestinal symptom severity when compared with taking placebo. However, the time to recovery of bowel function was reduced by about 0.7 days and there were modest improvements in defecation difficulty (110985).
Postpartum depression. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking a combination of B. lactis 420 DSM 22,089 and Lacticaseibacillus rhamnosus HN001 ATCC SD5675 (Dupont Nutrition & Health) 10 billion CFUs daily, alone or with fish oil providing eicosapentaenoic acid (EPA) 0.44 grams and docosahexaenoic acid (DHA) 3.8 grams daily, does not reduce symptoms of postpartum depression or anxiety when compared with placebo. Supplements were started in the second trimester of pregnancy and continued until 6 months after delivery (107496).
Prader-Willi syndrome (PWS). It is unclear if oral Bifidobacterium lactis is beneficial for PWS. Details: A small clinical trial in children with PWS shows that taking B. lactis BPL1 CECT8145 (Archer Daniels Midland Co-Biópolis) 10 billion colony-forming units (CFUs) daily for 12 weeks does not improve fat mass, abdominal adiposity, lipid profile, blood pressure, or glucose control when compared with placebo. However, there was a small improvement in insulin levels and measures of insulin resistance. Also, abdominal adiposity was modestly improved in a sub-group of patients over age 4.5 years, the age at which excessive weight gain typically starts in this population (105149). Other clinical research in children with PWS shows that taking B. lactis BL-11 (Beijing Huayuan Academy of Biotechnology) 30 billion CFUs twice daily for 12 weeks does not affect weight or psychological outcomes, including behavior, communication, and motor skills, when compared with placebo. However, height and overall clinical impression were modestly improved (107585).
Pregnancy-induced nausea and vomiting. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial shows that taking probiotics during pregnancy reduces the severity and duration of nausea and vomiting by 16% to 54%. There was also a small benefit on stool hardness. A specific probiotic (Probiotics 10, Nature's Bounty) was taken as 2 capsules daily for two back-to-back cycles comprised of six days with probiotics and two days without. Each capsule contained a total of 10 billion colony-forming units (CFUs) of B. lactis Bl-04, Lactiplantibacillus plantarum 299v and DSM 15312, Lactobacillus delbrueckii subsp. bulgaricus Lb-87, Lacticaseibacillus paracasei DSM 13434 and Lpc-37, Ligilactobacillus salivarius Ls-33, Levilactobacillus brevis Lbr-35, Lactobacillus acidophilus La-14, and Lacticaseibacillus casei Lc-11, along with inulin 200 mg (107199).
Prematurity. It is unclear if oral Bifidobacterium lactis is beneficial for preventing infections in premature infants. Details: A small clinical trial in very low birth weight premature infants shows that taking B. lactis BB-12 two billion colony-forming units per kg six times daily from birth for 6 weeks does not reduce the incidence of nosocomial infections when compared with taking placebo (110994). This study may have been too small to detect differences.
Psoriasis. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with psoriasis shows that taking a mixture of probiotics for 8 weeks modestly improves overall disease symptoms and feelings of depression when compared with placebo. The percentage of patients achieving at least a 50% or 75% reduction in overall symptom score was 40% and 24%, respectively, compared with 16% and 8% of those taking placebo. The probiotic was taken twice daily and provided a total daily dose of 2.6 billion colony-forming units (CFUs) of B. lactis, Bifidobacterium bifidum, Bifidobacterium longum, and Lactobacillus acidophilus (107498).
Radiation-induced diarrhea. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with cervical cancer receiving radiotherapy with or without chemotherapy shows that taking a specific product (Biogurt, Fame Pharmaceuticals) containing B. lactis BB-12 and Lactobacillus acidophilus LA-5 1.75 billion lyophilized live colony-forming units in a capsule three times daily throughout radiation treatment reduces the risk of diarrhea by 28% when compared with placebo. Taking probiotics also reduced the use of loperamide when compared with placebo (102285).
Rheumatoid arthritis (RA). Although there has been interest in using oral Bifidobacterium lactis for RA, there is insufficient reliable information about the clinical effects of B. lactis for this condition.
Rotaviral diarrhea. It is unclear if oral B. lactis is beneficial for rotaviral diarrhea. Details: Small clinical studies show that giving B. lactis BB-12 alone or along with Streptococcus thermophilus may help reduce the incidence of diarrhea and rotavirus shedding in infants and children up to 36 months old (3169).
Ulcerative colitis. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial shows that taking a specific product (Probio-Tec AB-25) containing B. lactis BB-12 and Lactobacillus acidophilus La-5 is not beneficial for preventing relapse in patients with ulcerative colitis when compared with placebo (95338).
Urinary tract infections (UTIs). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients in adults and children; its effect when used alone is unclear. Details: In children aged 4 months to 5 years with a previous UTI, clinical research shows that taking a specific combination (Complete Probiotic Platinum) of B. lactis 750 million colony-forming units (CFUs), Bifidobacterium bifidum 200 million CFUs, Lactobacillus acidophilus 750 million CFUs, and Lacticaseibacillus rhamnosus 50 million CFUs per kg twice daily for 18 months increases the median time to the first incidence of recurrence by approximately 3 months and increases the percentage of children without a UTI during the study period from 83% to 97% (103436). However, in older adults in long-term care, taking a combination of B. lactis BB-12 and L. rhamnosus 13-16 billion CFUs daily does not reduce the incidence of UTI when compared with placebo over a 12-month period (103425).
Ventilator-associated pneumonia (VAP). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking B. lactis BB12 1.75 billion colony-forming units (CFUs), Lactobacillus acidophilus LA-5 1.75 billion CFUs, Lactiplantibacillus plantarum 500 million CFUs, and Saccharomyces boulardii 1.5 billion CFUs twice daily for 15 days reduces the risk of VAP to 12%, compared with 28% of patients taking placebo. Half of the dose was given onto the oropharynx and half via a nasogastric tube (107524). More evidence is needed to rate Bifidobacterium lactis for these uses.

LACTICASEIBACILLUS RHAMNOSUS (Lactobacillus rhamnosus GG)

POSSIBLY EFFECTIVE

Antibiotic-associated diarrhea. Oral Lacticaseibacillus rhamnosus GG seems to reduce the risk of antibiotic-associated diarrhea (AAD) in adults and children. Details: Meta-analyses of clinical research show that taking L. rhamnosus GG (Culturelle) can reduce the risk of AAD in adults and children (4371,4372,7306,8511,14334,90299,95348). This strain appears to reduce the risk of AAD by about 60% to 71% (14334,90299,95348,95398). Although some contradictory evidence exists (7306), a meta-analysis of clinical research shows that taking this strain is beneficial in both inpatient and outpatient populations (90299). In children, it has been used as 10-20 billion colony-forming units (CFUs) once daily or 20 billion CFUs twice daily, given throughout the conventional antimicrobial treatment period (4371,4372,8511,14334). In adults, it has been used as 6-40 billion CFUs daily (14334,95348). However, some research suggests that this strain may only be effective in children, not adults (95389). The effect of L. rhamnosus has also been examined in combination with other products. A meta-analysis of 5 clinical trials in hospitalized or outpatient adults shows that taking L. rhamnosus, usually in combination with other probiotic strains, reduces the risk of AAD by 29% when compared with taking placebo (107635). A number of combination products containing L. rhamnosus have demonstrated benefit for preventing AAD, including L. rhamnosus CLR2, Lactobacillus acidophilus CL1285, and Lacticaseibacillus casei LBC80R (Bio-K+ Cl1285) 100 billion CFUs daily (95402,95403,25494); L. rhamnosus R0011 7.6 billion CFUs and Lactobacillus helveticus R0052 0.4 billion CFUs daily (Lacidofil STRONG, Lallemand Health Solutions) (96891); and Bifidobacterium bifidum NIZO 3804, Bifidobacterium animalis subsp. lactis NIZO 3680, Enterococcus faecium NIZO 3886, L. acidophilus NIZO 3678 and NIZO 3887, Lacticaseibacillus paracasei NIZO 3672, Lactiplantibacillus plantarum NIZO 3684, L. rhamnosus NIZO 3689, and Ligilactobacillus salivarius NIZO 3675 (Ecologic AAD) (95405). However, some combination products containing L. rhamnosus have not demonstrated benefit with respect to AAD prevention. In older adults in long-term care, taking a combination of L. rhamnosus and Bifidobacterium animalis subsp. lactis (BB-12) daily does not reduce the incidence or number of days with AAD over a 12-month period when compared with placebo (103425). In a small clinical trial in children aged 5 months to 16 years, taking a combination of L. rhamnosus KL53A, L. plantarum PL02, and Bifidobacterium longum PL03 twice daily during antibiotic treatment does not reduce the rate of AAD when compared with placebo. However, there was a modest reduction in the number of stools each day (107553). An additional large clinical trial in children aged 3 months and up shows that taking L. rhamnosus in combination with other probiotics does not reduce the risk of antibiotic-associated diarrhea when compared with taking placebo, when the more stringent definition is considered excluding diarrhea of other etiologies. However, the risk of diarrhea of any etiology is reduced by 35%. The probiotic supplement provided a total of 10 billion CFUs of L. rhamnosus W71, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Lacticaseibacillus paracasei W20, Lactiplantibacillus plantarum W62, Ligilactobacillus salivarius W24, Bifidobacterium bifidum W23, and Bifidobacterium animalis subsp. lactis W51 daily from the first day of antibiotic treatment until 7 days after treatment ended (110969).
Atopic dermatitis (eczema). Oral live Lacticaseibacillus rhamnosus, alone or in combination with other probiotics, seems to be beneficial for the treatment of atopic dermatitis in infants and children. It also seems to be beneficial for preventing atopic dermatitis when taken by the infant after exposure during pregnancy, but it is unclear if taking L. rhamnosus only during pregnancy or lactation is beneficial for preventing atopic dermatitis. Details: A meta-analysis of the available clinical research shows that various species of lactobacilli reduce the severity of atopic dermatitis in infants and children up to 36 months of age. Children with moderate to severe disease seem to obtain greater benefit from supplementation than those with mild disease (98436). One specific strain has shown benefit. Clinical research in infants shows that taking L. rhamnosus GG in extensively hydrolyzed whey formula providing approximately 30 billion colony-forming units (CFUs) per kg daily modestly reduces symptom severity when compared with taking placebo (107528). Other clinical research in children ages 6-36 months shows that taking L. rhamnosus GG 10 billion CFUs daily for 12 weeks more than doubles the proportion of patients with a clinically important reduction in severity when compared with taking placebo. These benefits lasted for at least 4 weeks post-supplementation. The number of days without rescue medication was reduced by about 3 days (112491). Some clinical research also shows that L. rhamnosus GG (Culturelle) might be beneficial for reducing symptoms of atopic dermatitis in infants who are allergic to cow's milk (4369). L. rhamnosus has also been shown to have beneficial effects when used in combination with other probiotics. Examples include a specific mixture (Latopic, Biomed S.A.) providing 1 billion CFUs of L. rhamnosus ŁOCK 0900 25%, L. rhamnosus ŁOCK 0908 25%, and Lacticaseibacillus casei ŁOCK 0919 50% for 3 months in children under 2 years of age (107510), and a combination of lyophilized L. rhamnosus 19070-2 and Limosilactobacillus reuteri DSM 122460 as 10 billion CFUs of each strain twice daily for 6 weeks in children aged 1-13 years (12773). Heat-killed L. rhamnosus has also been evaluated. In children aged 1-12 years with moderate atopic dermatitis, taking heat-killed L. rhamnosus IDCC 3201 (RHT3201) 10 billion CFUs daily for 12 weeks modestly reduces overall symptom severity when compared with placebo. However, these benefits were not shown in the intention to treat analysis. Also, the use of topical corticosteroids was not reduced (107527). Limited research has also evaluated oral L. rhamnosus for the treatment of atopic dermatitis in adults. One clinical study shows that taking 1 billion CFUs each of L. rhamnosus LRH020, Lactiplantbacillus plantarum PBS067, and L. reuteri PBS072 for 56 days modestly reduces the severity of symptoms and improves skin smoothness and moisturization for up to an additional 28 days when compared with placebo (107506). Other research has investigated the effects of L. rhamnosus for the PREVENTION of atopic dermatitis. A meta-analysis of clinical research shows that perinatal use of L. rhamnosus alone or in combination with other probiotics reduces the incidence of atopic dermatitis by up to 40% in children up to 2 years of age or 6-7 years of age. However, this benefit did not occur in children ages 4-5 years or 10-11 years. In these studies, L. rhamnosus was used prenatally and then possibly postnatally during lactation and/or supplemented to the newborn (112494). The reason for the age-related discrepancy is unclear; however, the number of studies investigating the effect of L. rhamnosus in children over 2 years of age was small. When lactobacilli-based probiotics are used during gestation and then supplemented to the newborn during the first 2-24 months of life, additional meta-analyses of clinical research show that this reduces the risk of the child developing atopic dermatitis by up to 40%. Most of the studies included in these analysis used L. rhamnosus GG or HN001 alone or in combination with other probiotics (90247,107503). Regimens used in some clinical research include L. rhamnosus HN001 as 6 billion CFUs daily from 35 weeks' gestation until 6 months after delivery in adults or 6 billion CFUs daily from birth to 2 years old (90603), L. rhamnosus HN001 starting at 14 weeks' gestation and continuing until 6 months postpartum (98437), as well as combinations of L. rhamnosus and Bifidobacterium animalis subsp. Lactis 1 billion CFUs daily for 6 months (102286), L. rhamnosus LPR and Bifidobacterium longum BL999 (90285), and L. rhamnosus GG, Lactobacillus acidophilus La-5, and Bifidobacterium animalis subsp. Lactis BB-12 in fermented milk starting at 36 weeks' gestation and continuing until 3 months' postpartum (96893). Some research has investigated differences between the various perinatal dosing schedules. Subgroup analyses of clinical research show that the incidence of atopic dermatitis is reduced by 48% and 34% in infants receiving L. rhamnosus prenatally and then during lactation OR via direct supplementation, respectively. However, the incidence of atopic dermatitis was not reduced in infants receiving L. rhamnosus prenatally and then during lactation AND via direct supplementation (112494). The reason for this discrepancy is unclear but may be related to the different forms of supplementation, levels found in the body, and/or the age of the child at diagnosis (98437,112494).
Atopic disease. Taking oral Lacticaseibacillus rhamnosus GG during pregnancy and when breastfeeding, or giving it to the infant, seems to prevent atopic disease in infants and children. Details: Clinical research shows that L. rhamnosus GG (Culturelle), 10-20 billion colony-forming units (CFUs) daily taken orally 2-4 weeks before delivery and continued for the first 3-6 months of breastfeeding, prevents atopic disease (e.g., asthma, allergic rhinitis, and eczema) in infants with a family history of atopy. It appears to be equally effective when taken while breastfeeding or when taken by the bottle-feeding infant (7743,8515,11381). For the bottle-feeding infant, L. rhamnosus GG was given as 10-20 billion CFUs daily in formula (Nutramigen LGG, Mead Johnson Nutrition) for the first 3-36 months of life (7743,8515). The preventive effect of this strain in at-risk infants appears to extend up to 7 years of age (11381,99791). Other research shows that L. rhamnosus HN001, 6 billion CFUs daily taken from 35 weeks' gestation and then continued in the infant until 2 years of age, reduces the risk of atopic dermatitis by 43% and rhinoconjunctivitis by 62% when compared with placebo at 4 years of age (90603). These preventive effects appear to extend up to 11 years of age (99791). Clinical research in infants with cow's milk allergy also shows that adding L. rhamnosus GG to a hydrolyzed casein infant formula (Nutramigen LGG, Mead Johnson Nutrition) reduces the overall occurrence of other allergic manifestations when compared with casein infant formula alone. Approximately 4 infants need to take this supplemented formula in order to prevent one allergic manifestation, such as eczema, rash, asthma, and runny nose or eyes. The tolerance to cow's milk allergy is also improved over the next 3 years (96889). However, not all strains or methods of administration appear to be beneficial. Intake of L. rhamnosus HN001 only during gestation and postpartum, without supplementation in the infant, does not reduce the infant's risk of developing atopic manifestations by 12 months of age when compared with placebo. This strain was not detected in breastmilk and did not alter breastmilk protein or cytokine concentrations, which might explain these disparate findings (98437).

POSSIBLY INEFFECTIVE

Critical illness (trauma). Enteral Lacticaseibacillus rhamnosus does not seem to be beneficial for patients with critical illness. Details: A large clinical trial in critically ill patients on mechanical ventilation shows that giving L. rhamnosus GG 10 billion colony-forming units (CFUs) enterally twice daily for a median of 9 days and up to 60 days does not reduce the risk of developing ICU-acquired infections or diarrhea or alter mortality or length of stay when compared with placebo. Also, in 15 patients, L. rhamnosus GG was isolated from sterile sites, including the blood, peritoneal or pleural fluid, hepatic or intra-abdominal abscess, or urine. Death occurred in two cases (107499).
Peanut allergy. Oral Lacticaseibacillus rhamnosus does not seem to be beneficial for increasing the efficacy of peanut oral immunotherapy in children. Details: Clinical research in children aged 1-10 years with peanut allergy shows that taking L. rhamnosus ATCC 53103 20 billion colony-forming units (CFUs) daily for 18 months does not increase the efficacy of peanut oral immunotherapy in inducing desensitization or maintenance of sustained unresponsiveness to peanuts over the next 8 weeks. Taking L. rhamnosus decreased the number of gastrointestinal and respiratory adverse events; however, hypersensitivity and urticaria occurred more frequently in children aged 6-10 years taking L. rhamnosus (107525).
Ventilator-associated pneumonia (VAP). Most research shows that enteral Lacticaseibacillus rhamnosus does not prevent VAP and might increase the risk of L. rhamnosus infection. Details: A large clinical trial in critically ill patients on mechanical ventilation shows that giving L. rhamnosus GG 10 billion colony-forming units (CFUs) enterally twice daily for a median of 9 days and up to 60 days does not reduce the risk of developing VAP when compared with placebo. Also, in 15 patients, L. rhamnosus GG was isolated from sterile sites, including the blood, peritoneal or pleural fluid, hepatic or intra-abdominal abscess, or urine. Death occurred in two cases (107499). In contrast, a small clinical study in critically ill patients suggests that administering L. rhamnosus GG (Culturelle) 2 billion CFUs twice daily might reduce the incidence of VAP to 19%, compared with 40% in the placebo group. In this study, half of the dose was given onto the oropharynx and half via a nasogastric tube (17116).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Abdominal pain. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for abdominal pain. Details: A meta-analysis of clinical research in children 4-18 years old with functional abdominal pain shows that taking L. rhamnosus GG does not reduce abdominal pain when compared with placebo (105130).
Age-related cognitive decline. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for age-related cognitive decline. Details: In healthy middle-aged and older adults, clinical research shows that taking L. rhamnosus GG (Culturelle) 10 billion colony-forming units daily for 3 months does not improve cognitive function when compared with placebo. However, there was some benefit in a sub-group of individuals with cognitive impairment (105134).
Allergic rhinitis (hay fever). Oral Lacticaseibacillus rhamnosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that drinking 250 mL of fermented milk containing L. rhamnosus GG 50 billion colony-forming units (CFUs), Lactobacillus acidophilus La-5 5 billion CFUs, and Bifidobacterium animalis subsp. lactis BB-12 50 billion CFUs from 36 weeks' gestation until 3 months postpartum does not reduce the incidence of allergic rhinitis in the child at 6 years of age when compared with placebo milk (96893).
Attention deficit-hyperactivity disorder (ADHD). Although there has been interest in using oral Lacticaseibacillus rhamnosus for ADHD prevention or treatment, there is insufficient reliable information about the clinical effects of L. rhamnosus for this purpose.
Bacterial vaginosis. Oral and vaginal Lacticaseibacillus rhamnosus have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: A clinical trial shows that using vaginal capsules (EcoVag Vaginal Capsules, Bifodan A/S) containing L. rhamnosus and Lactobacillus gasseri, 100 million to 1 billion colony-forming units (CFUs) of each strain per capsule, following conventional treatment for 10 days in three subsequent menstrual cycles, increases the time from cure to relapse when compared with placebo. However, cure rates were not significantly improved in the first month of treatment (16745). Oral L. rhamnosus has also been evaluated. The available clinical research has investigated the use of a specific strain, GR-1 in combination with Limosilactobacillus reuteri RC-14. Some research suggests that this combination does not modify vaginal or fecal microbiota or improve cure or recurrence rates in patients also treated with metronidazole vaginally, when compared with taking placebo (111996,111998). Doses in these studies included at least 1 billion CFUs daily of L. rhamnosus plus L. reuteri for 30 days in otherwise healthy premenopausal adults (111996) or 2 billion CFUs of L. rhamnosus and L. reuteri twice daily for 6 months in patients with HIV (111998). However, other clinical research in patients with bacterial vaginosis suggests that taking this combination of probiotics might be beneficial for improving cure rates and improving the vaginal microbiota. In these studies, cure rates increased from 40%-50% with placebo to approximately 88% with the L. rhamnosus and L. reuteri combination. In addition to a single dose of tinidazole 2 grams or metronidazole treatment, 2 billion CFUs each of L. rhamnosus and L. reuteri were used daily for about 1 month in these studies (111997,112508). The reasons for these discrepancies are unclear but may be related to the differences in patient populations, geographical locations, and/or dosing of the product. The effect of L. rhamnosus GR-1 and L. reuteri RC-14 for the prevention of bacterial vaginosis has also been investigated. One clinical study shows that taking capsules containing 2.5 billion CFUs of this combination daily from 9-14 weeks' gestation until delivery does not affect the rate of bacterial vaginosis when compared with placebo (102292). In patients with HIV treated with metronidazole 400 mg twice daily for 10 days, taking 2 billion CFUs of L. rhamnosus and L. reuteri twice daily for 6 months does not improve the recurrence rates when compared with taking placebo (111998).
Bipolar disorder. Oral Lacticaseibacillus rhamnosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study shows that taking at least 100 million colony-forming units of a combination of L. rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 for 24 weeks after discharge from the hospital for mania reduces the time to first rehospitalization when compared with placebo. The hazard ratio for the first rehospitalization due to worsening of psychiatric symptoms was 0.37 for the combination probiotic group when compared with placebo. Among patients who were re-hospitalized, taking the combination probiotic reduced the mean duration of rehospitalization by 5.4 days when compared with placebo (96896).
Cancer. Although there has been interest in using oral Lacticaseibacillus rhamnosus for cancer prevention or treatment, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Canker sores. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for canker sore prevention or treatment. Details: A systematic review and meta-analysis of mainly small and preliminary clinical trials shows that oral lactobacilli have a small effect on pain from canker sores. However, only two studies in the analysis used L. rhamnosus. One individual study shows that taking L. rhamnosus Lcr35 1.5 billion colony-forming units (CFUs) daily for 3 months has no effect on the number of canker sores. Another small study shows that taking a combination of L. rhamnosus, Lacticaseibacillus paracasei, Lactobacillus acidophilus, and Bifidobacterium animalis subsp. lactis reduces pain, but does not affect the number of lesions or healing time, when compared with placebo (105146). The individual studies were small and may have been underpowered to detect a difference between groups.
Chemotherapy-induced diarrhea. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for preventing chemotherapy-induced diarrhea. Details: Preliminary clinical research in patients with colorectal cancer receiving chemotherapy with 5-fluorouracil shows that taking L. rhamnosus GG (Culturelle) 10-20 billion colony-forming units (CFUs) daily in two divided doses orally during 24 weeks of chemotherapy, with or without guar gum, reduces severe diarrhea, abdominal discomfort, and the number of chemotherapy dose reductions required when compared with not taking L. rhamnosus GG (16736).
Child development. Oral Lacticaseibacillus rhamnosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An 11-year follow-up study shows that taking L. rhamnosus and Bifidobacterium animalis subsp. lactis daily from 35 weeks' gestation until birth, or for six months after birth if breastfeeding, followed by supplementation of the child until two years of age, does not affect neurocognitive outcomes such as attention, intelligence, executive function, depression, and anxiety, when compared with placebo (102287).
Clostridioides difficile infection. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for the prevention of C. difficile infection. Details: Observational research has found that providing a specific combination (Bio-K+ 50 Billion; Bio-K Plus International) of L. rhamnosus CLR2, Lactobacillus acidophilus CL1285, and Lacticaseibacillus casei LBC80R, as 50-100 billion colony-forming units (CFUs) daily for 5 days to patients who are on antibiotics for at least 2 days reduces the hospital-wide incidence of C. difficile by approximately 40%. The incidence rate was decreased by at least 50% in the highest risk individuals taking this combination (107529). Conversely, individual clinical studies included in some meta-analyses suggest that L. rhamnosus is not effective for the primary prevention of C. difficile infections; however, the number of patients with C. difficile in the individual studies is likely too small for an adequate comparison (14334,90231). Current guidelines from the Infectious Diseases Society of America (IDSA) state that there is insufficient information to recommend administration of probiotics for the primary prevention of C. difficile-associated diarrhea (107538). While some preliminary clinical research shows that taking L. rhamnosus GG might reduce the risk of C. difficile diarrhea recurrence (4392,4394), meta-analyses of more recent, higher-quality clinical data show that this strain is not effective for this purpose (14334,18088,90934,95368,95370).
Cognitive function. It is unclear if oral Lacticaseibacillus rhamnosus improves cognitive function in young adults. Details: A small clinical trial shows that taking L. rhamnosus JB-1 as 1 billion colony-forming units daily for 4 weeks does not improve cognitive function when compared with placebo in healthy young adults (105148).
Cognitive impairment. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for cognitive impairment. Details: In middle-aged and older adults with cognitive impairment, a small clinical trial shows that taking L. rhamnosus GG (Culturelle) 10 billion colony-forming units daily for 3 months results in an improved cognitive function score when compared with placebo (105134).
Colic. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for colic. Details: A small clinical trial in exclusively breastfed infants with colic shows that taking L. rhamnosus ATCC 53103 5 billion colony-forming units (CFUs) daily for 28 days reduces full-force crying time by a median of 135 minutes when compared with taking placebo (112000). Other clinical research in infants aged 4-12 weeks with colic shows that taking a combination of L. rhamnosus and Limosilactobacillus reuteri (FloraActive) 250 million CFUs with fructo-oligosaccharides 3.33 mg and vitamin D3 200 IU daily for 28 days reduces mean crying time by 2.7 hours by the end of the study, compared to a 1.9-hour reduction in the vitamin D group (99783). However, another small clinical study in infants shows that taking L. rhamnosus GG 10 billion CFUs with inulin 225 mg daily starting within 4 days of birth does not prevent colic symptoms or diagnosis at 4 months when compared with inulin alone (112497). This study was a secondary analysis of a trial designed to investigate the effect of L. rhamnosus on atopic disease prevention.
Common cold. Although there has been interest in using oral Lacticaseibacillus rhamnosus for preventing the common cold, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Constipation. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for constipation. Details: A small clinical study in children less than 5 years old with functional constipation shows that taking L. rhamnosus Lcr35 800 million CFUs twice daily for 4 weeks does not improve stool frequency when compared with placebo (95340). However, a small clinical trial shows that taking a combination of L. rhamnosus IDCC 3201, Lactiplantibacillus plantarum IDCC 3501, Lacticaseibacillus casei IDCC 3451, Bifidobacterium animalis subsp. lactis IDCC 4301, Bifidobacterium breve IDCC 4401, Lactococcus lactis IDCC 2301, xylooligosaccharide, and dietary fiber as nondigestible maltodextrin, oat fiber, and psyllium husk fiber (ID-HWS1000) modestly increases stool frequency and improves symptoms of functional constipation in adults when compared with placebo (107517). It is unclear if these effects are due to L. rhamnosus, other ingredients, or the combination.
Coronavirus disease 2019 (COVID-19). Although there has been interest in using oral Lacticaseibacillus rhamnosus for reducing symptoms of COVID-19, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Crohn disease. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for preventing Crohn disease recurrence. Details: A small clinical trial in adults shows that taking L. rhamnosus GG (Culturelle) 6 billion colony-forming units (CFUs) twice daily for one year does not prevent recurrence of Crohn disease after surgery (12767). Another small clinical trial in children and young adults shows that taking L. rhamnosus 10 billion CFUs twice daily for up to two years in addition to standard therapy does not prolong remission when compared with placebo (107539).
Cystic fibrosis. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for cystic fibrosis. Details: Clinical research in children aged 2-16 years with cystic fibrosis shows that taking L. rhamnosus GG 6 billion colony-forming units (CFUs) daily for 12 months does not reduce the odds of having at least one pulmonary exacerbation, the odds of hospitalization over 12 months, or the total number of exacerbations or hospitalizations when compared with placebo (107570).
Dental caries. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for dental caries prevention. Details: A large clinical trial in children aged 1-6 years shows that providing milk containing L. rhamnosus GG ATCC 53103 (Gefilus, Valio Ltd., Riihimaki Dairy) five days a week for 7 months does not reduce the overall odds of developing dental caries when compared with placebo. However, there was a 44% reduction in caries odds when caries risk was taken into consideration. The milk provided at least 500,000 colony-forming units (CFUs) per mL, with each child consuming 42-584 mL daily (107571). However, a meta-analysis of this and other large clinical trials in preschool children shows that taking L. rhamnosus in juice or milk modestly reduces the incidence of dental caries and prevents tooth decay progression when compared with taking placebo (112507). The effect of L. rhamnosus added to milk has also been investigated in adults. Clinical research in middle-aged and older adults with at least two primary root caries lesions shows that taking L. rhamnosus LB21 200 million CFUs in milk, either alone or with added fluoride 5 ppm, once daily for 15 months modestly reduces lesion severity when compared with placebo milk. However, the milk containing L. rhamnosus in the absence of fluoride was less effective than either the combination or the milk containing fluoride only (107573). The validity of this study is limited by a dropout rate of 38%.
Dental plaque. Oral Lacticaseibacillus rhamnosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in adolescent males aged 13-15 years with mild to moderate gingival inflammation shows that taking two lozenges containing L. rhamnosus GG (Probiotical SpA) and Bifidobacterium animalis subsp. lactis BB-12 (Chr. Hansen A/S) twice daily for 4 weeks does not reduce plaque when compared with placebo. However, here was a benefit on levels of some salivary and plaque pathogenic bacteria. Each lozenge provided L. rhamnosus 440 million colony-forming units (CFUs) plus B. animalis subsp. lactis BB-12 480 million CFUs (107574). A small clinical trial in healthy adults shows that taking four lozenges daily providing a total daily dose of 2 billion CFUs each of L. rhamnosus GG ATCC 53103 (Probiotical SpA) and B. animalis subsp. lactis BB-12 DSM 15954 (Chr. Hansen A/S) for 4 weeks modestly reduces plaque and gingivitis when compared with placebo (107572). Another small clinical trial in adults with moderate gingival inflammation shows that taking a tablet providing 50 million CFUs each of L. rhamnosus PB01 DSM 14869 and Latilactobacillus curvatus EB10 DSM 32307 twice daily after brushing for 4 weeks does not improve plaque or bleeding during probing when compared with placebo (107575).
Denture stomatitis. Although there has been interest in using oral Lacticaseibacillus rhamnosus for denture stomatitis, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Diabetes. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for treatment of type 1 or type 2 diabetes. Oral L. rhamnosus is unlikely to be beneficial for the prevention of gestational diabetes and may actually increase the risk for other complications. Details: One small clinical study in patients with type 2 diabetes shows that taking a specific combination product (Familact probiotics, ZistTakhmir Co.) containing L. rhamnosus and other probiotic bacteria daily for 6 weeks does not reduce fasting blood glucose or plasma insulin when compared with placebo. This product contains L. rhamnosus 1.5 billion colony-forming units (CFUs), Lactobacillus acidophilus 2 billion CFUs, Lacticaseibacillus casei 7 billion CFUs, Lactobacillus delbrueckii subsp. bulgaricus 200 million CFUs, Bifidobacterium breve 30 billion CFUs, Bifidobacterium longum 7 billion CFUs, and Streptococcus thermophilus 1.5 billion CFUs (99790). A meta-analysis of clinical research shows that taking lactobacilli, usually L. rhamnosus, during pregnancy is unlikely to PREVENT gestational diabetes and increases the relative risk of pre-eclampsia by 85% when compared with placebo (105185). Studies have used L. rhamnosus HN001 6 billion CFUs daily from 14-16 weeks' gestation to 24-30 weeks' gestation (96888), L. rhamnosus GG and Bifidobacterium animalis subsp. lactis (BB-12) at least 1 billion CFUs daily from 16-20 weeks' gestation until 28 weeks' gestation, or L. rhamnosus HN001 ATCC SD5675 and B. animalis subsp. lactis 420 DSM 22089 (Dupont Nutrition & Health) 10 billion CFUs each daily throughout pregnancy, with or without fish oil (102284,105144). Limited evidence has also assessed the effects of L. rhamnosus for type 2 diabetes. Taking L. rhamnosus 10 billion CFUs, L. acidophilus 1 billion CFUs, and Bacillus coagulans GanedenBC30 (GBI-30, 6086) 100 billion CFUs with fructo-oligosaccharides 500 mg daily for 12 weeks modestly reduces fasting blood glucose and insulin and improves measures of insulin resistance when compared with placebo (107536). Some research has also assessed the effects of L. rhamnosus in combination with other probiotics in children 8-17 years old with new onset type 1 diabetes. One clinical study shows that taking L. rhamnosus GG ATCC 53103 and Bifidobacterium animalis subsp. lactis Bb12 DSM 15954 1 billion CFUs daily for 6 months does not reduce insulin requirements or glycated hemoglobin over 12 months when compared with placebo. Additionally, C-peptide levels and the maintenance of residual pancreatic beta-cell function were not affected when compared with placebo (107518).
Diarrhea. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for the prevention or treatment of acute diarrhea. Details: L. rhamnosus GG (e.g., Culturelle) 6 billion CFUs twice daily, given prophylactically at hospital admission, seems to reduce the risk of non-rotaviral diarrhea in infants and children ages 1-36 months (7741). Furthermore, giving 37 billion CFUs of this strain daily, 6 days weekly for 15 months, can reduce the occurrence of diarrhea from all causes in undernourished children aged 6-24 months (4373). However, in older adults in long-term care, taking a combination of L. rhamnosus and Bifidobacterium animalis subsp. lactis (BB-12) 13-16 billion CFUs daily does not reduce the incidence or duration of diarrhea over a 12-month period when compared with placebo (103425). A small clinical study in children with dysentery being treated with ceftriaxone shows that taking a specific combination probiotic sachet (Kidilact, Zisttakhmir Company) containing L. rhamnosus, Lacticaseibacillus casei, Lactobacillus acidophilus, Lactobacillus delbrueckii subsp. bulgaricus, Bifidobacterium infantis, Bifidobacterium breve, and Streptococcus thermophilus daily for 5 days modestly reduces the duration of diarrhea, hospitalization, and blood in diarrhea when compared with control (102417). L. rhamnosus has yielded inconsistent results in the treatment of acute gastroenteritis, which is defined as three or more episodes of watery stools per day, with or without vomiting, for fewer than 3-7 days. While the European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388), both guidelines note that most evidence is low quality. Furthermore, these guidelines were published prior to the completion of the recent high-quality studies showing no benefit with L. rhamnosus GG, alone or in combination with Lactobacillus helveticus (98427,98428,103441,110925). These studies in children 3 months to 4 years of age with acute gastroenteritis show that taking either L. rhamnosus GG (e.g., Culturelle) 1 billion CFUs or a combination product containing L. rhamnosus GG 3.8 billion CFUs and L. helveticus 200 million CFUs twice daily for 5 days does not reduce the risk of a moderate to severe episode of acute gastroenteritis in the 14-28 days after starting the probiotic when compared with placebo (98427,98428,103441,110925). These products also did not reduce the incidence or severity of diarrhea or vomiting, the number of unexpected healthcare visits (98427,98428,103441,110925), the number of day care days missed, or the rate of household transmission (98427) when compared with placebo, regardless of the causative pathogen. Additional clinical research shows that treatment with L. rhamnosus GG 1 billion CFUs twice daily for 5 days does not reduce the severity or duration of diarrhea in otherwise healthy children 6 months to 6 years of age (90280).
Gingivitis. Oral Lacticaseibacillus rhamnosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in adolescent males aged 13-15 years with mild to moderate gingival inflammation shows that taking two lozenges containing L. rhamnosus GG (Probiotical SpA) and Bifidobacterium animalis subsp. lactis BB-12 (Chr. Hansen A/S) twice daily for 4 weeks modestly reduces gingivitis when compared with placebo. Each lozenge provided L. rhamnosus 440 million colony-forming units (CFUs) plus B. animalis subsp. lactis BB-12 480 million CFUs (107574). A small clinical trial in healthy adults shows that taking four lozenges daily providing a total daily dose of 2 billion CFUs each of L. rhamnosus GG ATCC 53103 (Probiotical SpA) and B. animalis subsp. lactis BB-12 DSM 15954 (Chr. Hansen A/S) for 4 weeks modestly reduces plaque and gingivitis when compared with placebo (107572). However, a small clinical trial in adults with moderate gingival inflammation shows that taking a tablet providing 50 million CFUs each of L. rhamnosus PB01 DSM 14869 and Latilactobacillus curvatus EB10 DSM 32307 twice daily after brushing for 4 weeks does not improve plaque or bleeding with probing when compared with placebo (107575).
Group B streptococcal colonization. Oral Lacticaseibacillus rhamnosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of two clinical trials shows that taking L. rhamnosus GR-1 and Limosilactobacillus reuteri RC-14, starting at 35-37 weeks' gestation and continuing until delivery, does not improve GBS clearance during pregnancy. However, a well-designed study included in this analysis shows that taking 4 billion CFUs daily more than doubles the number of patients testing negative for GBS at delivery (105165). In addition, a small clinical trial shows that taking this combination as 2.5 billion colony-forming units (CFUs) each daily for 12 weeks, starting at weeks 23-25 of gestation, does not prevent the rate of GBS vaginal/rectal colonization at 35-37 weeks' gestation (107567).
Helicobacter pylori. It is unclear if oral Lacticaseibacillus rhamnosus in combination with standard therapies for H. pylori can improve eradication rates or reduce the risk of adverse effects; the available research is conflicting. Details: Most clinical research in adults has shown that L. rhamnosus does not improve H. pylori eradication rates when used in combination with Lactobacillus acidophilus, Bifidobacterium bifidum, and Streptococcus faecium and taken with triple therapy consisting of furazolidone, tetracycline, and lansoprazole (90279), when used in combination with six other probiotics species and taken with bismuth quadruple therapy (90291), or when L. rhamnosus GG is used with triple therapy consisting of rabeprazole, clarithromycin, and tinidazole (12763). However, a large, more recent study shows that taking L. rhamnosus GG in combination with Bifidobacterium animalis subsp. lactic BB-12 (Normia, JGL; Christian Hanssen) twice daily for 14 days with triple therapy results in eradication in 87% of patients, compared with 73% of those taking triple therapy and placebo (107514). L. rhamnosus has also been evaluated for reducing the risk of adverse effects from H. pylori treatment. In two studies in which L. rhamnosus is taken along with other probiotics, the rate of adverse effects is not reduced when compared with placebo (90279,90291). However, when L. rhamnosus GG is used alone, or in combination with Bifidobacterium animalis subsp. lactis BB-12, triple therapy-related adverse effects are modestly reduced when compared with placebo (12763,107514). There was no longer a difference in adverse events between probiotic therapy and placebo during the 2-4 weeks of follow up (12763).
HIV/AIDS. Although there has been interest in using oral Lacticaseibacillus rhamnosus for HIV/AIDS, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Hypercholesterolemia. Although there has been interest in using oral Lacticaseibacillus rhamnosus for hypercholesterolemia, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Hypertension. Although there has been interest in using oral Lacticaseibacillus rhamnosus for hypertension, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Irritable bowel syndrome (IBS). It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for IBS; the available research is conflicting. Details: A meta-analysis of clinical research shows that L. rhamnosus reduces abdominal pain, but does not improve the frequency of pain relief, in patients with IBS (107594). In contrast, a small clinical trial shows that taking L. rhamnosus GG 10 billion CFUs daily for 8 weeks does not improve symptoms of IBS (12771). L. rhamnosus has also been evaluated in combination with other probiotics. Clinical research shows that taking a product (Duolac Care) containing L. rhamnosus, Bifidobacterium animalis susbp. lactis, Bifidobacterium breve, Lactobacillus acidophilus, Lactiplantibacillus plantarum, and Streptococcus thermophilus twice daily for 4 weeks can relieve symptoms in 72% of patients with IBS (95353). A clinical study in patients with diarrhea-predominant IBS (IBS-D) shows that taking a specific multi-species probiotic (NordBiotic, MBM Biotix) containing L. rhamnosus LR110, L. acidophilus LA120, L. plantarum LP140, Lacticaseibacillus paracasei LPC100, Lacticaseibacillus casei LC130, B. breve BB010, Bifidobacterium longum BL020, Bifidobacterium bifidum BF030, Bifidobacterium animalis subsp. lactis BL040, and Streptococcus thermophilus ST250 as 2.5 billion CFUs total twice daily for 8 weeks improves overall symptom severity, as well as pain severity, pain frequency, and quality of life, when compared with placebo. Symptom severity was rated as mild by approximately 60% of those taking the probiotic mixture, compared with 30% of those taking placebo (107516). However, other clinical research shows that taking a combination of L. rhamnosus CLR2, L. acidophilus CL1285, and L. casei LBC80R 50 billion CFUs each daily for 3 months does not improve symptoms of IBS in the whole study population, although it may have some benefit in specific sub-groups (99789).
Lactose intolerance. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for lactose intolerance. Details: In patients with persistent symptoms related to lactose intolerance despite a lactose-free diet, a small clinical trial shows that taking a combination product (Zircombi) containing L. rhamnosus HN001 1 billion CFUs, Bifidobacterium longum BB536 4 billion CFUs, and vitamin B6 1.4 mg daily for 30 days modestly improves symptoms of bloating and constipation, but not abdominal pain, when compared with placebo (105153).
Malnourishment-related diarrhea. Oral Lacticaseibacillus rhamnosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children aged 6 months to 4 years of age hospitalized with severe acute malnutrition shows that taking L. rhamnosus LGG and Bifidobacterium lactis BB-12 5 billion colony-forming units each daily during hospitalization and for 8-12 weeks as an outpatient does not affect diarrhea incidence or severity or the number of days with diarrhea during hospitalization. However, the number of days with diarrhea as an outpatient was reduced by 2.2 days (110996).
Malnutrition. Oral Lacticaseibacillus rhamnosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children aged 6 months to 4 years of age hospitalized with severe acute malnutrition shows that taking L. rhamnosus LGG and Bifidobacterium lactis BB-12 5 billion colony-forming units each daily during hospitalization and for 8-12 weeks as an outpatient does not affect pneumonia incidence, duration, or severity, weight gain, duration of hospitalization, or other outcomes (110996).
Metabolic syndrome. Although there has been interest in using oral Lacticaseibacillus rhamnosus for metabolic syndrome, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Necrotizing enterocolitis (NEC). It is unclear if oral Lacticaseibacillus rhamnosus is beneficial or safe for NEC prevention. Details: Most meta-analyses of clinical research show that giving lactobacilli enterally reduces the risk of NEC and/or severe NEC in preterm, mainly very low birth weight (VLBW), infants. Some meta-analyses support the use of lactobacilli in combination with bifidobacteria, as opposed to lactobacilli alone for reducing the risk of NEC (95344,95351,103437,103445,104157,105162,105164). However, research on the use of L. rhamnosus, specifically, is limited. Large retrospective reports suggest that taking L. rhamnosus GG does not significantly reduce the risk of NEC in preterm, VLBW infants. The most recent report suggests that the use of L. rhamnosus is associated with an almost 2-fold increased incidence of NEC when compared with not using L. rhamnosus (17121,112501). Also, guidance among regulatory agencies and clinical organizations varies with respect to the use of probiotics in very low birth weight infants under 1000 grams. The US Food and Drug Administration (FDA) warns that preterm infants given probiotics are at risk of serious infections caused by the bacteria or fungi contained in probiotics due to cases reported in this group of infants (111610). Also, The American Academy of Pediatrics does not support the routine administration of probiotics to preterm infants, particularly those with a birth weight below 1000 grams, due to conflicting data on safety and efficacy and potential for harm in this vulnerable population (111608). The Canadian Paediatric Society, the American Gastroenterological Association, and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition state that probiotic combinations may be of benefit in reducing the incidence of NEC in preterm neonates over 1000 grams. However, L. rhamnosus is not specifically recommended (103003,111609,111611).
Neurogenic bladder. Although there has been interest in using intravesical Lacticaseibacillus rhamnosus for reducing urinary symptoms associated with neurogenic bladder, there is insufficient reliable information about the clinical effects of L. rhamnosus for this purpose.
Nonalcoholic fatty liver disease (NAFLD). Oral Lacticaseibacillus rhamnosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In children with NAFLD, clinical research shows that taking a specific combination product (Prokid, Gostaresh Milad Pouya Company) containing L. rhamnosus DSMZ 21690 2 billion colony-forming units (CFUs), Lactobacillus acidophilus ATCC B3208 3 billion CFUs, Bifidobacterium animalis subsp. lactis DSMZ 32269 6 billion CFUs, and Bifidobacterium bifidum ATCC SD6576 2 billion CFUs daily for 12 weeks normalizes liver sonography findings in 53% of children, compared with 17% of those taking placebo. In addition, levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are reduced by 30% and 25%, respectively. There was no effect on body mass index or blood lipids when compared with placebo (105156).
Obesity. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for weight loss. Details: Clinical research in adults with obesity shows that taking L. rhamnosus 162 million colony-forming units (CFUs) twice daily for 24 weeks does not reduce body weight or fat mass when compared with placebo. However, when only females are considered, L. rhamnosus seems to reduce body weight by an additional 1.8 kg when compared with placebo (90289). Another clinical trial shows that taking 10 billion CFUs each of L. rhamnosus HN001 and Bifidobacterium animalis subsp. lactis 420 daily during pregnancy and for 6 months postpartum, alone or with 2 capsules daily of fish oil (Croda Europe Ltd.), reduces the odds of the infant being overweight at 24 months by at least 78% when compared with taking placebo (110336). It is unclear if this effect is related to L. rhamnosus, B. lactis, or their combination.
Oropharyngeal candidiasis. Although there has been interest in using oral Lacticaseibacillus rhamnosus for oropharyngeal candidiasis, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Osteoarthritis. Although there has been interest in using oral Lacticaseibacillus rhamnosus for osteoarthritis, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Otitis media. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for preventing otitis media in children. Details: Preliminary clinical research in children aged 1-6 years who attend daycare shows that taking milk containing L. rhamnosus GG (Culturelle) does not reduce the incidence of otitis media infections when compared with placebo (8565).
Periodontitis. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for periodontitis. Details: A meta-analysis of 2 small clinical trials in patients with periodontitis shows that using oral L. rhamnosus as an adjunctive therapy to scaling and root planing does not improve clinical attachment or reduce probing pocket depth when compared with control (107622). Similarly, a small clinical trial in patients with stage III periodontitis following scaling and root planing shows that taking L. rhamnosus SP1 (Macrofood S.A.) as 20 million colony-forming units (CFUs) daily for 3 months does not improve plaque, probing pocket depth, bleeding on probing, or clinical attachment, when compared with placebo (107576). However, all studies were small and might not have been adequately powered to detect differences between groups.
Polycystic ovary syndrome (PCOS). It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for PCOS. Details: A small clinical trial in overweight or obese patients with PCOS who are consuming an energy-restricted diet shows that taking L. rhamnosus 12 billion colony-forming units (CFUs) daily for 20 weeks does not increase weight loss or have beneficial effects on blood lipid levels when compared with placebo (107577). However, this study was small and may not have been adequately powered to detect a difference between groups. Another clinical trial shows that 31.3% of patients with PCOS taking L. rhamnosus in combination with other probiotics daily for 6 months had regular menstrual cycles compared with 12.5% of those taking placebo. There were also modest improvements in testosterone levels and waist circumference, but not other hormones, insulin resistance, body weight, or most measures of quality of life. The product provided L. rhamnosus UBLR-58 2 billion CFUs along with Bifidobacterium bifidum UBBB-55, Lactobacillus acidophilus UBLA-34, Lactiplantibacillus plantarum UBLP-40, Lacticaseibacillus casei UBLC-42, Limosilactobacillus fermentum UBLF-31, Limosilactobacillus reuteri UBLRu-87, and fructo-oligosaccharides (FOS) daily for 2 months and then twice daily for 4 months. All patients also underwent dietary and lifestyle changes (110974). It is unclear if any benefits are due to L. rhamnosus, the other probiotics, or their combination.
Postoperative bowel function. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for improving postoperative bowel function. Details: A small preliminary clinical trial shows that taking L. rhamnosus GG (Dicoflor 60, Vitis pharma, Warsaw, Poland) 6 million colony-forming units twice daily for 30 days following major pancreatic surgery reduces the time to first passing gas and stool, by about 1.1 and 2 days, respectively, when compared with receiving standard nutrition only (112495).
Postoperative infection. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for preventing postoperative infections. Details: A small preliminary clinical trial shows that taking L. rhamnosus GG (Dicoflor 60, Vitis pharma, Warsaw, Poland) 6 million colony-forming units twice daily for 30 days following major pancreatic surgery does not reduce the incidence of postoperative infections when compared with receiving standard nutrition only (112495).
Postoperative recovery. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for improving postoperative recovery. Details: A small preliminary clinical trial shows that taking L. rhamnosus GG (Dicoflor 60, Vitis pharma, Warsaw, Poland) 6 million colony-forming units twice daily for 30 days following major pancreatic surgery reduces the length of hospital stay by 2 days when compared with receiving standard nutrition only (112495).
Postpartum depression. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for postpartum depression. Details: Clinical research shows that taking L. rhamnosus HN001 6 billion colony-forming units (CFUs) daily from 14-16 weeks' gestation does not reduce the rate of clinically significant depression when compared with placebo. However, taking this product modestly reduces feelings of postpartum depression and anxiety, and 47% fewer patients experienced clinically significant anxiety between 1-2 months' postpartum when compared with placebo (107541). Other clinical research shows that taking a combination of L. rhamnosus HN001 ATCC SD5675 and Bifidobacterium animalis subsp. lactis 420 DSM 22,089 (Dupont Nutrition & Health) 10 billion CFUs daily, alone or with fish oil providing eicosapentaenoic acid (EPA) 0.44 grams and docosahexaenoic acid (DHA) 3.8 grams daily, does not reduce symptoms of postpartum depression or anxiety when compared with placebo. Supplements were started in the second trimester of pregnancy and continued until 6 months after delivery (107496).
Pouchitis. Although there has been interest in using oral Lacticaseibacillus rhamnosus for pouchitis, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Respiratory tract infections. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for respiratory tract infections; the available research is conflicting. Details: The evidence related to the use of L. rhamnosus for respiratory tract infections is mixed. A meta-analysis of clinical research shows that administering L. rhamnosus GG to infants and children reduces the risk of upper respiratory tract infections (URTIs) by about 38%. However, this analysis shows that giving this strain to infants and children does not reduce the risk of overall respiratory infections or the risk of lower respiratory tract infections (95347). Also, the evidence from individual clinical trials is mixed. One large clinical trial shows that children ages 1-6 years who attend daycare centers get fewer and less severe respiratory infections when given approximately 260 mL milk daily containing L. rhamnosus GG (Culturelle) 0.5-1 million colony-forming units (CFUs) per mL (8565). However, other clinical research in infants aged 6 to 12 months shows that taking L. rhamnosus HN001 one million colony-forming units (CFUs) per gram of follow-on formula daily for 12 weeks does not reduce the incidence of confirmed or parentally reported upper respiratory tract infections when compared with formula without added probiotics. Infants consumed an average of 141 grams of formula daily (110988). Also, a large clinical trial in children aged 2-6 years shows that taking L. rhamnosus GG 1 billion CFUs daily for 16 weeks does not reduce the incidence of physician-diagnosed URTIs when compared with taking placebo. There was also no difference in the number of children, days, or days absent with a URTI (112492). L. rhamnosus has also been investigated in combination with other probiotics. In college students, clinical research shows that taking L. rhamnosus GG and Bifidobacterium lactis BB-12 one billion CFUs each daily for 12 weeks reduces the duration of upper respiratory tract infection by about 2 days when compared with placebo. Symptom severity was reduced by 34%. There was also a small reduction in the number of missed school days, but not work days (110993). Conversely, in older adults in long-term care, taking a combination of L. rhamnosus and Bifidobacterium animalis subsp. lactis (BB-12) 13-16 billion CFUs daily does not reduce the incidence of upper or lower respiratory tract infections when compared with placebo over a 12-month period, and actually increases the use of antibiotics for lower respiratory tract infections by 2.2 days (103425).
Rheumatoid arthritis (RA). It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for RA. Details: A small clinical trial in patients with RA shows that taking L. rhamnosus GG ATCC 53103 (Gefilus, Valio Ltd.) 10 billion colony-forming units (CFUs) twice daily for 12 months does not reduce symptoms when compared with placebo (107533). An additional small clinical trial shows that taking a total of 2 billion colony-forming units (CFUs) daily of a combination of L. rhamnosus GR-1 and Limosilactobacillus reuteri RC-14 (Chr Hansen) for 14 weeks does not improve symptom severity when compared with placebo (107569). Both studies were small and may not have been adequately powered to detect differences between groups.
Rotaviral diarrhea. It is unclear if oral Lacticaseibacillus rhamnosus is beneficial for rotaviral diarrhea. Details: Some meta-analyses of clinical research and several small clinical trials show that L. rhamnosus GG (Culturelle) can reduce the duration of diarrhea in infants and children with rotavirus infection (1253,4369,4377,8568,112504). These studies were conducted prior to the availability of the rotavirus vaccine. Conversely, large, high-quality studies conducted after the introduction of the rotavirus vaccine do not show benefits (98427,98428,112504). Clinical research in children 3 months to 4 years of age with acute gastroenteritis, including rotaviral gastroenteritis, shows that taking either L. rhamnosus GG (Culturelle) or a combination product containing L. rhamnosus GG 3.8 billion CFUs and Lactobacillus helveticus 200 million CFUs twice daily for 5 days does not reduce the risk of a moderate to severe episode of acute gastroenteritis in the 14 days after starting the probiotic when compared with placebo (98427,98428,110925). Taking these probiotic products also does not reduce the incidence or severity of diarrhea or vomiting, the number of unexpected healthcare visits (98427,98428,110925), the number of daycare days missed, the rate of household transmission (98427), or the pathogen load (103441) when compared with placebo. Approximately 48% to 65% of the children enrolled in these studies were vaccinated against rotavirus, but it is not clear if this altered the study outcomes (98427,98428,103441). More research is needed to evaluate the effect of lactobacillus in the treatment of rotaviral diarrhea in children who have not been vaccinated against rotavirus. Although L. rhamnosus GG and other species have shown modest benefit in preliminary clinical studies in children who have not received the rotavirus vaccine, the evidence is conflicting, and not all of the evaluated patients had confirmed rotavirus infection (102295). The current guidelines related to the treatment of viral diarrhea are also conflicting. While the World Gastroenterology Organization has not made a recommendation (98471), the European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388). However, these guidelines note that most evidence is low quality and is not specific to rotavirus infection. Furthermore, these guidelines were released prior to the publication of the most recent, high-quality studies showing no benefit with the use of L. rhamnosus (98427,98428). Recent guidelines by the American Gastroenterology Association conditionally recommend against the use of probiotics for the treatment of acute infectious gastroenteritis in children (103003).
Short bowel syndrome. Although there has been interest in using oral Lacticaseibacillus rhamnosus for short bowel syndrome, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Small intestinal bacterial overgrowth (SIBO). Although there has been interest in using oral Lacticaseibacillus rhamnosus for SIBO, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Stress. It is unclear if oral Lacticaseibacillus rhamnosus GG is beneficial for stress. Details: Preliminary clinical research in university students shows that taking L. rhamnosus HN001 6 billion colony-forming units (CFUs) daily for 8-13 weeks during the semester does not reduce stress or anxiety during exams when compared with taking placebo (112496).
Travelers' diarrhea. It is unclear if oral Lacticaseibacillus rhamnosus GG is beneficial for the prevention of travelers' diarrhea; the available research is conflicting. Details: Clinical research shows that taking L. rhamnosus GG (Culturelle) 2 billion colony-forming units daily orally, starting two days prior to a trip and continuing until the end of the trip, seems to reduce the occurrence of diarrhea in child and adult travelers (4374,10216). However, a meta-analysis which included two small clinical studies evaluating the use of L. rhamnosus GG in adults traveling to different parts of the world found no benefit for the prevention of travelers' diarrhea when compared with placebo (101445). The effectiveness of this strain can vary significantly based upon the destination of travel. Destinations in the same country can have different results, probably due to differences in bacteria and other microorganisms at different locations (10216).
Ulcerative colitis. Although there has been interest in using oral Lacticaseibacillus rhamnosus for ulcerative colitis, there is insufficient reliable information about the clinical effects of L. rhamnosus for this condition.
Urinary tract infections (UTIs). It is unclear if oral or intravaginal Lacticaseibacillus rhamnosus is beneficial for the prevention or treatment of UTIs. Details: Some small clinical studies show that intravaginal use of L. rhamnosus might provide modest benefit for preventing UTI (6094,6095). These trials used suppositories containing 0.5 gram (1.6 billion colony-forming units (CFUs)) of L. rhamnosus and Limosilactobacillus fermentum twice weekly for 2 weeks, then once a month for 2 months (6095) or a vaginal solution containing L. rhamnosus 100 billion viable bacteria/mL in a dose of 1 mL twice weekly (6094). However, some research indicates that L. rhamnosus is ineffective in establishing vaginal colonization, regardless of the route of administration (90257). This may explain why studies which have evaluated the use of L. rhamnosus as a single agent for this indication have failed to show benefit (4581). Oral L. rhamnosus has also been evaluated for the prevention of UTI recurrence. Clinical research in postmenopausal adults shows that an oral combination of L. rhamnosus GR-1 and Limosilactobacillus reuteri RC-14, standardized to at least 1 billion CFUs and taken twice daily for 12 months, demonstrates similar efficacy to trimethoprim/sulfamethoxazole 480 mg once daily for reducing the number of symptomatic UTIs. Although this combination was not associated with the increase in antimicrobial resistance that occurred with the use of antibiotic prophylaxis, the antibiotic delayed the median time to first recurrence by two-fold and reduced the number of confirmed microbiological infections when compared with lactobacillus (90235). In children aged 4 months to 5 years with a previous UTI, clinical research shows that taking a specific combination (Complete Probiotic Platinum) of L. rhamnosus, Lactobacillus acidophilus, Bifidobacterium bifidum, and Bifidobacterium animalis subsp. lactis for 18 months increases the median time to the first incidence of recurrence by approximately 3 months and increases the percentage of children without a UTI during the study period from 83% to 97% (103436). However, in older adults in long-term care, taking a combination of L. rhamnosus and Bifidobacterium animalis subsp. lactis (BB-12) 13-16 billion CFUs daily does not reduce the incidence of UTI when compared with placebo over a 12-month period (103425).
Vaginal candidiasis. It is unclear if oral or intravaginal Lacticaseibacillus rhamnosus is beneficial for the prevention or treatment of vaginal candidiasis. Details: A combination of L. rhamnosus and Bifidobacterium longum (Lactobac) given orally, or a combination of L. rhamnosus, Lactobacillus delbrueckii, Lactobacillus acidophilus, and Streptococcus thermophilus (Femilac) given intravaginally, does not seem to reduce the risk of vaginal candidiasis infection following use of antibiotics (12108). However, there is preliminary evidence that individuals with candidiasis who use intravaginal suppositories containing 1 billion colony-forming units of L. rhamnosus GG twice daily for 7 days in combination with conventional treatment might have subjective improvement in symptoms (4397). More evidence is needed to rate Lacticaseibacillus rhamnosus for these uses.

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Safety view details

Below is general information about the safety of the known ingredients contained in the product Probiotic Solutions Prenatal 20 Billion CFUs. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS

LIKELY SAFE ...when used orally and appropriately. Bifidobacterium lactis has been safely used alone or in combination with other probiotics in clinical trials lasting up to 12 weeks (92255,98502,105158,107572,107581,107586,110979,110985,110986,110992)(110993,110998,110999).

CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages. Bifidobacterium lactis has been safely used alone or in combination with other probiotics in infants and children for up to 15 months (3169,3458,92265,95381,95382,98736,105149,107582,107583,107585)(107587,107590,110984,110987,110988,110991,110994,110995). A combination probiotic containing B. lactis and Lactobacillus acidophilus (HOWARU Protect, Danisco) has been used safely for up to 6 months in children aged 3-5 years (16847). A specific combination of B. lactis, Bifidobacterium bifidum, and L. acidophilus (Complete Probiotic Platinum) has also been used safely for up to 18 months in children aged 4 months to 5 years (103436). In addition, in children ages 4-17 years, 1 billion CFUs of a 1:1:1 combination of B. lactis CECT 8145, Lacticasebacillus casei CECT 9104, and Bifidobacterium longum CECT 7347 has been used safely for 12 weeks (107531). There is insufficient reliable information available about the safety of B. lactis in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).

PREGNANCY AND LACTATION:
Insufficient reliable information available. A meta-analysis of four clinical trials shows that taking probiotics during pregnancy increases the relative risk of pre-eclampsia by 85% when compared with placebo. Although the specific effects of Bifidobacterium lactis are unclear from this analysis, three of the included studies used B. lactis in combination with Lacticaseibacillus rhamnosus (105185). More information is needed to determine if certain patients are at increased risk.

LACTICASEIBACILLUS RHAMNOSUS (Lactobacillus rhamnosus GG)

LIKELY SAFE ...when used orally and appropriately. Lacticaseibacillus rhamnosus has been safely used alone or in combination with other probiotics in studies lasting up to 6 months (4367,12108,35393,105134,107569,107572,107573,107575,107577,111793)(111996,111997,111998,112493,112496,112503,112508). ...when used intravaginally and appropriately. L. rhamnosus has been used safely in studies lasting from one week to six months (4397,12108,90283,111999). There is insufficient reliable information available about the safety of non-viable, heat-killed L. rhamnosus formulations when used orally.

CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages. The strain Lacticaseibacillus rhamnosus GG has been used safely in studies lasting from five days to 36 months (4369,4372,4373,4377,7741,8565,8566,8567,8568,14334)(90280,96889,98427,98428,99782,107518,107539,107571,110988,112000)(112491,112492,112494,112502). L. rhamnosus LOCK 0900 has been used safely in combination with other probiotics for 3 months (107510). There is insufficient reliable information about the safety of non-viable, heat-killed L. rhamnosus formulations in children when taken orally. Also, there is insufficient reliable information available about the safety of L. rhamnosus in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given L. rhamnosus and other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).

PREGNANCY: POSSIBLY SAFE
when used orally and appropriately. Lacticaseibacillus rhamnosus GG has been used with apparent safety starting 2-4 weeks before delivery (7743,8515). L. rhamnosus HN001 has been used from 14-16 weeks' gestation until 6 months post-delivery (96888,98437). The combination of L. rhamnosus with Bifidobacterium longum has been used from 2 months prior to delivery until 2 months after delivery or throughout pregnancy (90285,105128,105144). The combination of L. rhamnosus GR-1 and Limosilactobacillus reuteri RC-14 has been used for up to two trimesters during pregnancy (102292,107562). A combination of L. rhamnosus, Lactobacillus jensenii, Lactobacillus crispatus, and Lactobacillus gasseri has been used safely for 3-4 weeks from 32-36 weeks' gestation (105131). A meta-analysis of four clinical trials shows that taking probiotics during pregnancy increases the relative risk of pre-eclampsia by 85% when compared with placebo. Although the specific effects of L. rhamnosus are unclear from this analysis, two of the included studies used L. rhamnosus GG and one used L. rhamnosus HN001 (105185). More information is needed to determine if certain patients are at increased risk.

LACTATION: POSSIBLY SAFE
when used orally and appropriately. Lacticaseibacillus rhamnosus GG has been used with apparent safety when breastfeeding for up to six months (7743,8515) and L. rhamnosus HN001 has been used from 14-16 weeks' gestation until 6 months post-delivery (96888,98437). A combination of L. rhamnosus and Bifidobacterium longum has been used with apparent safety from 2 months prior to delivery until 2 months after delivery (90285).

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Interactions with Drugs view details

Below is general information about the interactions of the known ingredients contained in the product Probiotic Solutions Prenatal 20 Billion CFUs. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS

ANTIBIOTIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, taking Bifidobacterium lactis with antibiotic drugs might decrease the effectiveness of B. lactis.

Details

Since B. lactis preparations usually contain live and active organisms, simultaneously taking antibiotics might kill a significant number of the organisms (1740,22802). Tell patients to separate administration of antibiotics and B. lactis preparations by at least 2 hours.

LACTICASEIBACILLUS RHAMNOSUS (Lactobacillus rhamnosus GG)

ANTIBIOTIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Mild • Occurrence = Probable • Level of Evidence = D

Theoretically, taking Lacticaseibacillus rhamnosus with antibiotic drugs might decrease the effectiveness of L. rhamnosus.

Details

L. rhamnosus preparations usually contain live and active organisms. Therefore, simultaneously taking antibiotics might kill a significant number of the organisms (1740). Tell patients to separate administration of antibiotics and L. rhamnosus preparations by at least two hours.

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Adverse Effects view details

Report an Adverse Reaction to Probiotic Solutions Prenatal 20 Billion CFUs

Below is general information about the adverse effects of the known ingredients contained in the product Probiotic Solutions Prenatal 20 Billion CFUs. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS

General ...Orally, Bifidobacterium lactis seems to be well tolerated by most patients.
Most Common Adverse Effects:
Orally: Diarrhea.
Serious Adverse Effects (Rare):
Orally: There is concern that probiotics may cause infections in some people.

Dermatologic ...In clinical research, two cases of rash, one with itching, were reported by patients taking a combination of Bifidobacterium lactis BB-12, Lacticaseibacillus paracasei F19, and Lactobacillus acidophilus La5. However, it is not clear if these adverse effects were due to B. lactis, other probiotics, or the combination, or if the events were idiosyncratic (90236).

Gastrointestinal ...Bloating and flatulence have been reported with probiotic use; however, these adverse effects have not been reported from ingestion of Bifidobacterium lactis in particular. When taken orally, B. lactis can cause diarrhea and other gastrointestinal complaints in children (3169,95381,105149). Gastrointestinal complaints including worsening diarrhea, abdominal pain, constipation, stomach burn, and flatulence have been reported rarely (110986,110999).

Immunologic ...There have been cases of Bifidobacterium bacteremia in critically ill patients (102416,107599). These cases are rare and none seem to be due to Bifidobacterium lactis alone.
A specific preparation (NBL probiotic ATP, Nobel) containing B. lactis, Lacticaseibacillus casei, Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, fructo-oligosaccharides, galacto-oligosaccharides, colostrum, and lactoferrin was found to be a significant risk factor for vancomycin-resistant Enterococcus colonization in premature infants. Although there was no direct link to determine causation, it was hypothesized that the probiotic mixture helped to mediate the acquisition and transfer of antibiotic resistance genes (96890).

LACTICASEIBACILLUS RHAMNOSUS (Lactobacillus rhamnosus GG)

General ...Orally, Lacticaseibacillus rhamnosus is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that L. rhamnosus may cause infections in some people.

Gastrointestinal ...Orally, taking Lacticaseibacillus rhamnosus alone or in combination with other probiotics may cause gastrointestinal side effects including diarrhea (90235); however, these events are uncommon. In one small clinical study in infants with suspected cow's milk allergy who were receiving extensively hydrolyzed whey formula, diarrhea occurred in 5 of 13 infants receiving non-viable, heat-killed L. rhamnosus, compared with 0 of 14 infants receiving live L. rhamnosus and 0 of 8 infants receiving placebo (107528).
A 31-year-old male developed severe L. rhamnosus GG stomatitis and oral ulcers while undergoing induction chemotherapy for acute myeloid leukemia. The strain in the ulcers was determined to be the same strain that had been consumed in dairy products (112506).

Immunologic ...Since Lacticaseibacillus rhamnosus preparations contain live and active microorganisms, there is some concern that they might cause pathological infection in some patients. Some lactobacilli species have been isolated in some cases of bacteremia, sepsis, splenic abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, and meningoencephalitis. Most of these cases are thought to be due to the translocation of bacteria from other locations in the body in which they occur naturally, such as the oral cavity and gastrointestinal system, in ill and/or immunocompromised patients, or in patients otherwise at risk of infection. However, there are also rare case reports of pathological infections possibly to intake of L. rhamnosus products in these populations (4380,4390,4391,4398,8561,13008,13070,90298,103444,105138)(105139,105141,107543,111613,112499,112505,112509,112536).
Case reports exist of bacteremia or sepsis associated with L. rhamnosus use in infants and children. In infants, some cases have occurred following the use of L. rhamnosus for the treatment or prevention of diarrhea. These cases include a severely ill 6-week-old infant given L. rhamnosus GG (Culturelle) for antibiotic-associated diarrhea (13008), a 6-day old with intrauterine growth restriction given L. rhamnosus GG to prevent antibiotic-associated diarrhea (112509), a 3-month-old infant given L. rhamnosus GG for the prevention of antibiotic-associated diarrhea, and a 18-day-old preterm, very-low-birthweight infant given L. rhamnosus GG for the prevention of necrotizing enterocolitis (111613). In other cases, infants with short bowel syndrome have developed bacteremia (13008,112536). One case report involved an 11-month-old infant receiving L. rhamnosus for 5 weeks through a gastrostomy tube for rotaviral diarrhea (13070). Lactobacillus sepsis has also occurred in a 6-year-old child with cerebral palsy following use of L. rhamnosus GG (Culturelle) for intermittent diarrhea (13008). A 17-year-old male with ulcerative colitis developed bacteremia following once daily use of L. rhamnosus GG 1 billion colony-forming units (CFUs) (Culturelle, ConAgra Foods) (90298).
There are also cases of L. rhamnosus bacteremia or sepsis in adults. Fatal L. rhamnosus septicemia has been reported in an immunocompromised patient consuming yogurt and taking prolonged courses of multiple broad spectrum antibiotics (8561). A 50-year-old male developed L. rhamnosus endocarditis following daily use of a probiotic product providing at least 5 billion CFUs of L. rhamnosus. Although the patient was considered healthy, the role of a previous diagnosis of an unspecified heart murmur or an untreated deep gingival cut 3 months prior to endocarditis diagnosis may have increased the risk of infection (105139). A 56-year-old immunocompetent female developed L. rhamnosus GG bacteremia. She was hospitalized with an indwelling catheter following a motor vehicle accident and had been given this strain following the onset of diarrhea via a nasogastric tube as per hospital protocol (112499). There is also a case of L. rhamnosus sepsis in a male in his late 60s with a bioprosthetic aortic valve. He was taking L. rhamnosus for ulcerative colitis and developed sepsis along with aortic valve endocarditis and septic emboli to the brain (112505).
A specific probiotic preparation (NBL probiotic ATP, Nobel) containing L. rhamnosus, Lacticaseibacillus casei, Lactiplantibacillus plantarum, Bifidobacterium animalis subsp. lactis, fructo-oligosaccharides, galacto-oligosaccharides, colostrum, and lactoferrin was found to be a significant risk factor for vancomycin-resistant Enterococcus colonization in premature infants. Although there was no direct link to determine causation, it was hypothesized that the probiotic mixture helped to mediate the acquisition and transfer of antibiotic resistance genes (96890).

Report an Adverse Reaction to Probiotic Solutions Prenatal 20 Billion CFUs

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