Daily Probiotic Drops by Zarbee's Naturals Baby

POSSIBLY INEFFECTIVE

• Age-related cognitive decline. Oral Bifidobacterium breve does not seem to improve cognition in older adults. Details: A small clinical study in patients over 65 years of age shows that taking a sachet (Morinaga Milk Industry Co., Ltd) containing lyophilized powder of B. breve M-16V and B-3 and Bifidobacterium longum BB536 and M-63 as 12.5 billion colony-forming units each with water daily for 12 weeks does not improve cognition as measured on the Montreal Cognitive Assessment (MoCA) when compared with placebo (102412). While the results of this study may have been limited by the small population size, a larger clinical study in adults ages 50-80 years with subjective memory complaints also shows that using the same product for the same duration does not improve cognition when compared with placebo (102414).
• Sepsis. Oral Bifidobacterium breve does not seem to prevent sepsis in preterm infants. Details: One large, well-designed clinical study in preterm infants shows that taking B. breve BBG-001 up to about 90 billion colony-forming units (CFUs) daily in formula does not reduce the risk of sepsis when compared with placebo (92256). An additional smaller clinical trial also shows that taking B. breve M-16V 3 billion CFUs daily does not reduce the risk of sepsis (111008).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in children ages 4-17 years with allergic rhinitis and intermittent asthma related to Parietaria officinalis pollen shows that taking a combination of B. breve M-16 V one billion colony-forming units (CFUs), Bifidobacterium longum subsp. infantis M-63 one billion CFUs, and B. longum subsp. longum BB536 3 billion CFUs daily for 8 weeks modestly improves symptoms of rhinitis and quality of life when compared to taking placebo. There was no difference in the use of rescue medication (111001).
• Antibiotic-associated diarrhea. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in hospitalized patients with antibiotic-associated diarrhea shows that taking a combination of B. breve 50 million colony-forming units (CFUs) and Lacticaseibacillus casei 20 million CFUs three times daily does not reduce the average duration of diarrhea, the frequency of healing, or relapse rates, when compared with taking placebo (111006).
• Asthma. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large clinical trial in children ages 3-14 years with asthma shows that taking a combination of B. breve B632 (DSM 24706) and Ligilactobacillus salivarius LS01 (DSM 22775) one billion colony-forming units (CFUs) each twice daily for 8 weeks and then once daily for 8 weeks modestly reduces the number of asthma exacerbations. The odds of having one or two asthma exacerbation was more than three fold in children taking placebo when compared with children taking probiotics. There was no effect on the duration of exacerbation or use of corticosteroids (111004).
• Atopic dermatitis (eczema). Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a total of 10 billion colony-forming units (CFUs) daily of a combination of B. breve M-16V and Bifidobacterium longum subsp. longum BB536 from about 4 weeks before the expected due date until delivery and then giving 5 billion CFUs of this combination daily to the infant for 6 months reduces the odds of developing atopic dermatitis by up to 77% before 18 months of age when compared with no probiotic (111015).
• Atopic disease. Although there has been interest in using oral Bifidobacterium breve for preventing and treating atopic disease, there is insufficient reliable information about the clinical effects of B. breve for this use.
• Celiac disease. Although there has been interest in using oral Bifidobacterium breve for celiac disease, there is insufficient reliable information about the clinical effects of B. breve for this condition.
• Chemotherapy-related infection. Although there has been interest in using oral Bifidobacterium breve for preventing chemotherapy-related infections, there is insufficient reliable information about the clinical effects of B. breve for this purpose.
• Clostridioides difficile infection. Although there has been interest in using oral Bifidobacterium breve for C. difficile infection, there is insufficient reliable information about the clinical effects of B. breve for this condition.
• Cognitive impairment. It is unclear if oral Bifidobacterium breve is beneficial for cognitive impairment. Details: Clinical research in older adults with suspected mild cognitive impairment shows that taking B. breve A1 (MCC1274) 20 billion colony-forming units daily for 16 weeks improves some measures of cognitive function, including immediate and delayed memory, as well as visual spatial ability, by moderate amounts when compared with placebo. However, there was no effect on language or attention (103447). However, taking the same dose for 24 weeks does not improve most measures of cognitive function (111002).
• Colic. It is unclear if oral Bifidobacterium breve is beneficial for colic. Details: Preliminary clinical research in infants with colic shows that adding B. breve CECT7263 200 million colony-forming units (CFUs) daily, or a combination of B. breve with Limosilactobacillus fermentum CECT5716 as 100 million CFUs each daily, to human milk, formula, or water for 28 days reduces the time spent crying per week by approximately 160-200 minutes from baseline. Taking B. breve is at least as effective as taking simethicone 20 mg four times daily (105150). Other clinical research shows that taking B. breve B632 and BR03 100 million CFUs each daily for 3 months modestly reduces daily crying duration when compared with taking placebo (111010). B. breve has also been investigated for colic prevention. Clinical research in infants without colic at baseline shows that adding B. breve CECT7263 10 million CFUs per gram to formula modestly reduces the number of infants crying more than three hours daily when compared with a control formula. At 6 weeks of age, 12% of infants taking formula supplemented with B. breve cried more than 3 hours daily, compared with 29% of those using the control formula. At 4 months of age, frequency of crying more than 3 hours daily was low and not significantly different between groups (105151). However, this study was not specifically designed to examine the effects of B. breve on colic frequency as the infants did not have colic at baseline.
• Constipation. Most early research shows that oral Bifidobacterium breve seems to be beneficial for constipation. Details: Preliminary clinical research in children aged 3-16 years with functional constipation shows that taking a specific B. breve powder (Yakult, Yakult Honsha Co., Ltd.) 1-100 billion colony-forming units (CFUs) daily for 4 weeks increases defecation frequency by about 4 times per week, decreases episodes of fecal incontinence by about 7.5 episodes per week, and improves stool consistency and episodes of abdominal pain (17726). Multi-strain probiotics containing bifidobacteria have also been evaluated for constipation. In children with chronic constipation, preliminary clinical research shows that taking a combination of B. breve M-16 V, Bifidobacterium longum M-63, and B. longum BB536 daily for 8 weeks in addition to polyethylene glycol (PEG), does not improve symptoms or increase the rate of clinical remission when compared with PEG alone (107600). However, one meta-analysis of clinical research in adults with functional constipation shows that taking B. breve DSM 16604 and Lactiplantibacillus plantarum LMG P-21021 as 5 billion CFUs total daily for 30 days improves bowel movement frequency by about 1.5 stools weekly when compared with placebo (95342). Also, a small clinical trial shows that taking a specific combination product (ID-HWS1000) containing Lacticaseibacillus rhamnosus IDCC 3201, L. 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 modestly increases stool frequency and improves symptoms of functional constipation in adults when compared with placebo (107517).
• Depression. It is unclear if oral Bifidobacterium breve is beneficial for depression. Details: A small clinical trial in patients with major depressive disorder shows that taking B. breve CCFM1025 10 billion colony-forming units (CFUs) daily for 4 weeks modestly improves symptoms of depression when compared with placebo (107602).
• Diabetes. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients for various forms of diabetes; its effect when used alone is unclear. Details: One small clinical study in patients with type 2 diabetes shows that taking a specific combination product (Familact probiotics, ZistTakhmir Co.) containing B. breve and other probiotics daily for 6 weeks does not reduce fasting blood glucose or plasma insulin levels when compared with placebo. This product contains B. breve 30 billion colony-forming units (CFUs), B. longum 7 billion CFUs, Lactobacillus acidophilus 2 billion CFUs, Lacticaseibacillus casei 7 billion CFUs, Lactocaseibacillus rhamnosus 1.5 billion CFUs, Lactobacillus delbrueckii subsp. bulgaricus 200 million CFUs, and Streptococcus thermophilus 1.5 billion CFUs (99790). In adults with gestational diabetes, one clinical study shows that taking a specific product (Visbiome, ExeGi Pharma) containing B. breve and various other probiotics as a total of 112.5 billion CFUs twice daily for 8 weeks does not affect levels of fasting blood glucose or glycated hemoglobin (HbA1c) when compared with placebo. However, there were small improvements in insulin levels and insulin resistance (107549). A combination probiotic containing B. breve has also been evaluated in children 2-12 years of age with new-onset type 1 diabetes. One clinical study shows that taking Visbiome as 112.5 billion CFUs daily for 3 months modestly decreases HbA1c and insulin requirements when compared with placebo. Also, about three times as many children achieved remission, defined as insulin requirements of less than 0.5 U/kg daily and HbA1c levels of less than 7%. However, C-peptide levels and the maintenance of residual pancreatic beta-cell function were not affected when compared with placebo (107497). It is unclear if any benefits are due to B. breve, other probiotics, or the combinations.
• Diarrhea. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in children with dysentery being treated with ceftriaxone shows that taking a specific combination probiotic sachet (Kidilact, Zisttakhmir Company) containing B. breve, Lacticaseibacillus casei, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Lactobacillus delbrueckii subsp. bulgaricus, Bifidobacterium longum, and Streptococcus thermophilus daily for 5 days modestly reduces the duration of diarrhea, hospitalization, and blood in diarrhea when compared with control (102417). A large clinical trial in infants aged 4-6 months shows that taking an infant formula fermented with B. breve C50 and Streptococcus thermophilus 065 (Calisma) for about 5 months does not affect the incidence or duration of diarrhea episodes when compared with a standard infant formula. However, there was a modest reduction in severity of diarrhea episodes, based on reductions in proportions of infants with dehydration, consultations with medical providers, and need for oral rehydration (111106). This formula did not provide live B. breve.
• Exercise-induced muscle soreness. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in resistance-trained males shows that taking B. breve BR03 and Streptococcus thermophilus FP4 as 10 billion colony-forming units total daily for 3 weeks prior to resistance training modestly attenuates range of motion decrements, but does not seem to significantly decrease overall muscle soreness, when compared with placebo (95415).
• Helicobacter pylori. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In adults with H. pylori infection and peptic ulcer disease, adding a combination product containing seven strains of probiotics (Balance by Protexin Co) daily for 14 days to quadruple therapy with omeprazole, bismuth subcitrate, amoxicillin, and clarithromycin does not improve H. pylori eradication or symptoms when compared with quadruple therapy alone. This product provided B. breve, Lacticasebacillus casei, L acticasebacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus delbrueckii subsp. bulgaricus, Bifidobacterium longum, and Streptococcus thermophilus (90291).
• Irritable bowel syndrome (IBS). Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical study shows that taking a specific combination product (Visbiome, ExeGi Pharma) containing B. breve and other probiotics as 450 billion CFUs daily for 8 weeks decreases bloating in patients with diarrhea-predominant IBS (IBS-D) (11379). However, adding this product as 900 billion CFUs daily to a sham diet or a low-FODMAP diet for 4 weeks does not improve IBS symptoms when compared with placebo (98741). Other clinical research shows that taking a different product (Duolac Care) containing Lactobacillus acidophilus, Lactiplantibacillus plantarum, Lacticaseibacillus rhamnosus, Bifidobacterium breve, Bifidobacterium animalis subsp. lactis, Bifidobacterium longum, and Streptococcus thermophilus twice daily for 4 weeks can relieve symptoms in 72% of patients with IBS (95353). In addition, a clinical study in patients with IBS-D shows that taking a specific combination probiotic (NordBiotic, MBM Biotix) containing B. breve BB010, Lactobacillus acidophilus LA120, Lacticaseibacillus rhamnosus LR110, Lacticaseibacillus paracasei LPC100, Lacticaseibacillus casei LC130, Lactiplantibacillus plantarum LP140, B. 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).
• Metabolic syndrome. Although there has been interest in using oral Bifidobacterium breve for metabolic syndrome, there is insufficient reliable information about the clinical effects of B. breve for this condition.
• Necrotizing enterocolitis (NEC). It is unclear if oral Bifidobacterium breve is beneficial or safe for preventing NEC. Details: One large, well-designed clinical study in preterm infants shows that taking B. breve BBG-001 up to about 90 billion colony-forming units daily in formula does not reduce the risk of NEC when compared with placebo (92256). In a systematic review, four studies show that using B. breve does not reduce the incidence of NEC in most infants. However, in one of the included studies, although there was no effect on the incidence of NEC stage 2 in the total group or in infants born at less than 28 weeks' gestation, the incidence was reduced in infants born at less than 34 weeks' gestation. Also, other preliminary clinical research shows that giving B. breve alone or with Lacticaseibacillus casei reduces the incidence of NEC (107592,107595). 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. breve is not specifically recommended (103003,111609,111611).
• Nonalcoholic fatty liver disease (NAFLD). Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with NAFLD shows that taking two sachets daily for 3 months of a specific combination product (VSL#3) containing B. breve and other probiotics does not affect body mass index or most glycemic or lipid parameters when compared with taking placebo. However, there was a modest decrease in triglyceride levels and liver enzymes (111009).
• Obesity. It is unclear if oral Bifidobacterium breve is beneficial for obesity. Details: Clinical research in children aged 6-18 years with obesity and insulin resistance shows that adding B. breve BR03 (DSM 16604) and B632 (DSM 24706) 1 billion colony-forming units (CFUs) each daily for 8 weeks to advice on the Mediterranean diet and exercise modestly improves insulin sensitivity when compared with placebo. However, there was no difference between groups in body mass index (BMI) or blood pressure when compared with diet and exercise advice alone (107598). Additional clinical research in overweight, but non-obese, adults based on BMI shows that taking B. breve B-3 5 billion CFUs daily for 12 weeks modestly reduces body fat mass and waist and hip circumference when compared with taking placebo. However, there was no effect on body fat percentage or lipid endpoints (111003).
• Postoperative recovery. Although there has been interest in using oral Bifidobacterium breve for improving postoperative recovery, there is insufficient reliable information about the clinical effects of B. breve for this purpose.
• Pouchitis. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that continuous treatment with a specific combination product (Visbiome, ExeGi Pharma) containing B. breve and other probiotics as 6 grams (300-500 billion live bacteria per gram) daily for up to a year seems to maintain remission of pouchitis in 85% of patients (6087,12769).
• Radiation-induced diarrhea. Although there has been interest in using oral Bifidobacterium breve for preventing radiation-induced diarrhea, there is insufficient reliable information about the clinical effects of B. breve for this purpose.
• Respiratory tract infections. Although there has been interest in using oral Bifidobacterium breve for preventing respiratory tract infections, there is insufficient reliable information about the clinical effects of B. breve for this purpose.
• Rotaviral diarrhea. Although there has been interest in using oral Bifidobacterium breve for rotaviral diarrhea, there is insufficient reliable information about the clinical effects of B. breve for this condition.
• Short bowel syndrome. Although there has been interest in using oral Bifidobacterium breve for short bowel syndrome, there is insufficient reliable information about the clinical effects of B. breve for this condition.
• Ulcerative colitis. It is unclear if oral Bifidobacterium breve is beneficial for ulcerative colitis. Details: Some clinical research has evaluated B. breve-containing probiotics for increasing remission rates in patients with ulcerative colitis. The best evidence is for a specific combination product (Visbiome, ExeGi Pharma). Doses of 3 grams (equivalent to 900 billion colony-forming units (CFUs)) once or twice daily has been used in combination with conventional treatment. In children aged 1-16 years, doses of 450-1800 billion CFUs for up to one year have been used (3261,14370,14371,16841,95337). A meta-analysis of clinical research shows that taking this probiotic can increase remission rates by about 1.7-fold when compared with placebo in adults and children with active ulcerative colitis (95337). There is also evidence that it is beneficial for improving remission rates in patients who do not adequately respond to conventional treatment (14371). Additionally, some preliminary clinical research shows that this specific product, taken as an adjunct to standard maintenance therapy, might help prevent relapse (3261,16841). Other preliminary clinical research shows that taking Visbiome or a fermented milk (Yakult, Yakult Honsha Co., Ltd.) containing B. breve, Bifidobacterium bifidum, and Lactobacillus acidophilus as an adjunct to standard maintenance therapy might help prevent relapse in ulcerative colitis patients (3261,12775,14338,16841). However, other research shows that taking B. breve Yakult is not beneficial for preventing ulcerative colitis relapse (98740). More evidence is needed to rate Bifidobacterium breve for these uses.

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LIKELY SAFE ...when used orally and appropriately. Bifidobacterium breve has been safely used alone or in combination with other probiotics in clinical trials lasting up to one year (3261,6087,11379,12769,12775,14338,14370,14371,103447,111002)(111003,111005).

CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages. Bifidobacterium breve has been safely used alone or in combination with other probiotics in infants and children for up to 12 months (17726,35377,92256,103449,105150,105151,107497,107598,111001)(111004,111008,111015). Cases of bacteremia have occurred rarely in children (107597). There is insufficient reliable information available about the safety of B. breve in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given B. breve or 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:
There is insufficient reliable information available about the safety of Bifidobacterium breve during pregnancy or lactation. However, there are currently no reasons to expect safety concerns when used appropriately.

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ANTIBIOTIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking Bifidobacterium breve with antibiotic drugs might decrease the effectiveness of B. breve.  Details Since B. breve 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. breve preparations by at least 2 hours.

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General ...Orally, Bifidobacterium breve seems to be well tolerated by most patients.
Serious Adverse Effects (Rare):
Orally: There is concern that B. breve may cause bacteremia in certain patients.

Gastrointestinal ...Bloating and flatulence have been reported with probiotic use; however, these adverse effects have not been reported from ingestion of Bifidobacterium breve in particular.

Immunologic ...There have been rare cases of Bifidobacterium bacteremia related to probiotic use in critically ill infants and adults (102416,107597,107599). In addition, cases of B. breve bacteremia have occurred in preterm infants or young children using probiotics (102416,107597). In a review of 298 term and preterm infants who were admitted to the neonatal intensive care unit of a hospital in Japan and received B. breve BBG-01 over a five-year period, bacteremia occurred in six patients (2%). Concomitant conditions included gastrointestinal perforation, food-induced enterocolitis syndrome, adhesive ileus, ileal volvulus, and aspiration pneumonia following esophageal atresia repair (107597). In one case report, B. breve BBG-01 was provided to an infant starting two days after birth and the day of surgery for an omphalocele. The infant also had bilious gastric fluid with elevated inflammatory markers. It is thought that the intestinal surgical repair might have led to the translocation of the ingested B. breve (107596).
Some cases of B. breve bacteremia do not seem to be directly related to probiotic use. There have been rare cases of B. breve bacteremia and necrotizing fasciitis in patients with type 2 diabetes. One patient had pre-existing chronic diabetic foot ulcers and the other had abscesses near the groin (111007,111011). A childhood history of frequent consumption of fermented beverages containing B. breve was thought to have resulted in B. breve in the intestinal flora of one of these patients, aged 42 years (111011). However, it is unclear if consumption of an unknown quantity of B. breve more than 20 years previously would play a role in this outcome. There is also a rare case of ventriculoperitoneal shunt B. breve infection possibly related to poor oral hygiene and dentition (111014).

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