| Ingredients | VSL#3 Capsules Contain |
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Eight Strains Of Lactic Acid Bacteria
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Streptococcus thermophilus
(Streptococcus thermophilus )
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(Bifidobacterium breve )
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(Bifidobacterium longum )
(Recently reclassified as B lactis.)
(Bifidobacterium longum Genus: Bifidobacterium Species: longum Note: Recently reclassified as B lactis. )
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(bifidobacterium infantis )
(Recently reclassified as B lactis.)
(Bifidobacterium infantis Genus: bifidobacterium Species: infantis Note: Recently reclassified as B lactis. )
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(Lactobacillus acidophilus )
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(Lactobacillus plantarum )
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(Lactobacillus paracasei )
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(Lactobacillus delbrueckii bulgaricus )
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Microcrystalline Cellulose
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Stearic Acid
(C18:0)
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Magnesium Stearate
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Vegetable Capsule
(Hydroxypropyl Methylcellulose)
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(SiO2)
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Below is general information about the effectiveness of the known ingredients contained in the product VSL#3 Capsules. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product VSL#3 Capsules. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
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.
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.
LIKELY SAFE ...when live or heat-killed Lacticaseibacillus paracasei are used orally and appropriately. Live L. paracasei alone or in combination with other probiotics has been safely used in studies lasting up to 4 years (6087,14370,14371,35393,35407,103440,105133,107555,107557,110979)(111937,111938,111940,111943,111948,111950,111951,111953,111954,111955)(111958,111959,112512,112513,112518,112519). Non-viable, heat-killed L. paracasei has been safely used in studies lasting up to 3 months (111939,111940,111947). There is insufficient reliable information available about the safety of live or non-viable, heat-killed L. paracasei when used topically.
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
Lacticaseibacillus paracasei alone or in combination with Limosilactobacillus fermentum has been used with apparent safety for up to 3 months in children 1-18 years old (98440). Also, live or heat-killed L. paracasei LP-33 has been used with apparent safety for 30 days in children aged 5 years and older (107532). In children ages 2-12 years, a specific combination product (Visbiome, ExeGi Pharma) containing L. paracasei and seven other probiotics has been used safely for 3 months (107497). Also, L. paracasei has been used with apparent safety in combination with Lactiplantibacillus plantarum for up to 12 weeks (107556). L. paracasei DN-114 011 has been taken safely for 90 days in children ages 3-6 years in fermented milk (DanActive, Dannon) (112515). There is insufficient reliable information available about the safety of L. paracasei 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: POSSIBLY SAFE
when used orally and appropriately.
A combination of Lacticaseibacillus paracasei and Bifidobacterium longum from 2 months prior to delivery until 2 months after delivery has been used with apparent safety (90285).
LIKELY SAFE ...when used orally and appropriately. Lactobacillus acidophilus has been safely used as part of multi-ingredient probiotic products in studies lasting up to nine months (1731,6087,14370,14371,90231,90296,92255,103438,12775,107581)(110950,110970,110979,110998,111785,111793). ...when used intravaginally and appropriately. L. acidophilus has been used safely in studies lasting up to 12 weeks (12108,13176,13177,90265). There is insufficient reliable information available about the safety of non-viable, heat-killed L. acidophilus formulations when used orally.
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
Lactobacillus acidophilus has been safely used for up to 5 days (96887). Also, combination probiotics containing L. acidophilus have been used with apparent safety in various doses and durations. L. acidophilus has been combined with Bifidobacterium animalis (HOWARU Protect, Danisco) for up to 6 months in children 3-5 years old (16847), with Bifidobacterium bifidum for 6 weeks (90602,96890), with Bifidobacterium bifidum and Bifidobacterium animalis subsp. lactis (Complete Probiotic Platinum) for 18 months in children 4 months to 5 years of age (103436), and in a specific product (Visbiome, ExeGi Pharma) containing a total of 8 species for 3 months in children 2-12 years old (107497). There is insufficient reliable information available about the safety of L. acidophilus 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: POSSIBLY SAFE
when used orally and appropriately.
A combination of Lactobacillus acidophilus, Lacticaseibacillus casei, and Bifidobacterium bifidum has been used with apparent safety for 6 weeks, starting at 24-28 weeks' gestation (95416,98430).
LACTATION:
There is insufficient reliable information available about the safety of Lactobacillus acidophilus during lactation.
However, there are currently no reasons to expect safety concerns when used appropriately.
LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods (7135,10470,92135). It is estimated that the average dietary intake of silicon is 20-50 mg daily (110029); however, there is currently no established recommended dietary allowance or tolerable upper intake level for silicon (7135,92136,95009,110029).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (7135,10470).
It is estimated that the average dietary intake of silicon is 20-50 mg daily (110029). There is insufficient reliable information available about the safety of silicon when used in larger, medicinal amounts; avoid using.
Below is general information about the interactions of the known ingredients contained in the product VSL#3 Capsules. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, taking Bifidobacterium lactis with antibiotic drugs might decrease the effectiveness of B. lactis.
 Details
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Theoretically, taking Bifidobacterium breve with antibiotic drugs might decrease the effectiveness of B. breve.
Details
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Theoretically, taking Lacticaseibacillus paracasei with antibiotic drugs might decrease the effectiveness of L. paracasei.
Details
L. paracasei 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. paracasei preparations by at least two hours.
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Theoretically, taking Lactobacillus acidophilus with antibiotic drugs might decrease the effectiveness of L. acidophilus.
Details
L. acidophilus 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. acidophilus preparations by at least two hours.
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Below is general information about the adverse effects of the known ingredients contained in the product VSL#3 Capsules. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
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).
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).
General
...Orally, Lacticaseibacillus paracasei is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that Lacticaseibacillus paracasei may cause infections in some people.
Dermatologic
...Orally, in one clinical trial, a combination of Lacticaseibacillus paracasei subsp.
paracasei F19, Lactobacillus acidophilus La-5, and Bifidobacterium animalis subsp. lactis BB-12 was associated with two cases of rash, one with itching. However, it is not clear if these adverse effects were due to L. paracasei, other ingredients, the combination, or if the events were idiosyncratic (90236).
Topically, a lotion containing the cell free supernatant of L. paracasei was rarely associated with erythema, itching, and scaling (111945).
Gastrointestinal
...Orally, taking Lacticaseibacillus paracasei alone or in combination with other probiotics may cause gastrointestinal side effects including dyspepsia (105133), flatulence (107497), nausea (111952), and bloating (107497,111952); however, these events are uncommon.
There are at least five case reports of acute cholecystitis for which a lactobacilli was thought to be the primary pathogen. In a 66-year-old female, vancomycin-resistant L. paracasei was the primary pathogen resulting in peritonitis secondary to a cholecystitis-induced gallbladder perforation. Although the patient reportedly ate 96-128 oz of yogurt each day, this yogurt was not believed to be associated with the cholecystitis (103443).
Immunologic ...Since Lacticaseibacillus paracasei preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. Lactobacilli species, including L. paracasei, have been isolated in some cases of bacteremia, sepsis, splenic abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, meningoencephalitis, and prosthetic joint infections. Most cases of L. paracasei infection are thought to be due to the translocation of bacteria from other locations in the body in which it occurs naturally, such as the oral cavity and gastrointestinal tract (107543,111942,111944,111946,90282). However, there are case reports of L. paracasei infections thought to be at least partially related to dietary or supplemental intake (90254,107546,95393). In a 77-year-old male who consumed yogurt containing L. paracasei daily, L. paracasei bacteremia with endocarditis was thought to be related to bacterial translocation from the colon following a colonoscopy (90254). In a 78-year-old male, L. paracasei bacteremia and endocarditis was thought to be related to daily use of probiotics; however, the specific species included in the product were not mentioned. Also, the patient was diagnosed with an aortic valve stenosis and had undergone dental treatment approximately 6 months previously, possibly increasing the risk for development of bacteremia (95393). In an immunocompetent 45-year-old male with no history of heart disease, consumption of yogurt containing L. paracasei for about 2.5 years was thought to be associated with the development of endocarditis (107546).
General
...Orally and intravaginally, Lactobacillus acidophilus is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Intravaginally: Vaginal discharge.
Serious Adverse Effects (Rare):
Orally: There is concern that L. acidophilus may cause infections in some people.
Dermatologic ...Orally, in one clinical trial, a combination of Lactobacillus acidophilus La-5, Lacticaseibacillus paracasei subsp. paracasei F19, and Bifidobacterium animalis subsp. lacltis BB-12 was associated with two cases of rash, one with itching. However, it is not clear if these adverse effects were due to L. acidophilus, other ingredients, the combination, or if the events were idiosyncratic (90236).
Gastrointestinal ...Orally, taking Lactobacillus acidophilus in combination with other probiotics may cause gastrointestinal side effects including epigastric discomfort (90239), abdominal pain (90239,90291,111785), dyspepsia (90239), flatulence (107497,107520), bloating (107497,111785), diarrhea (111785), vomiting (107537), and burping (90239); however, these events are uncommon.
Genitourinary ...Intravaginally, cream containing Lactobacillus acidophilus has been shown to cause increased vaginal discharge in about 5% of patients, compared to about 1% of patients receiving placebo cream (90237). Vaginal burning was reported by one person using intravaginal L. acidophilus and Limosilactobacillus fermentum in a clinical trial (111781).
Immunologic ...Since Lactobacillus acidophilus preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. L. acidophilus has been isolated in some cases of bacteremia, sepsis, splenic abscess, liver 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 tract (107543,111782,111792). L. acidophilus endophthalmitis has been reported rarely (111787,111795). In one case, it was related to intravitreal injections for age-related macular degeneration in a 90-year-old female with an intraocular lens (111787). In another, it occurred following cataract surgery (111795).
General
...Orally, silicon in the amounts found in food and water is not associated with adverse effects.
Serious Adverse Effects (Rare):
Inhaled: Crystalline silicon dioxide in the form of quartz dust found in industrial and occupational settings is associated with an increased risk of diseases such as silicosis, tuberculosis, chronic bronchitis, chronic obstructive pulmonary disease (COPD), lung cancer, glomerulonephritis, vasculitis, and rheumatoid arthritis.
Cardiovascular ...Case control studies have shown that occupational exposure to silicon dioxide-containing compounds may cause vasculitis (75114). Patients with occupational pulmonary silicosis may develop microscopic polyangiitis (inflammation of the blood vessels in the nose, sinuses, throat, lungs, and kidneys, also known as Wegener's granulomatosis).
Dermatologic ...Occupational silica exposure may be a risk factor for scleroderma, particularly in males (75099).
Genitourinary
...Limited reports in humans indicate that long-term use of large amounts of antacids containing magnesium trisilicate may be associated with urolithiasis and silicon-containing stones (11760,11861,75075,75103).
However, fewer than 30 cases associated with antacids containing silicates have been reported, despite these products being commercially available since the 1930s. Although exceptionally rare, silicon dioxide kidney stones can also occur without magnesium trisilicate ingestion (11556). Their formation is caused by an acidic urinary pH. In at least one case, urine alkalinization resulted in resolution of the symptoms (75075).
Case-control studies have shown that occupational exposure to silicon dioxide is related to antineutrophil cytoplasmic antibody (ANCA)-associated glomerulonephritis (75114). High silicon levels in patients undergoing chronic hemodialysis have been associated with nephropathy (75089).
Hepatic ...High silicon levels in patients undergoing chronic hemodialysis have been associated with liver disease (75089).
Musculoskeletal ...High silicon levels in patients undergoing chronic hemodialysis have been associated with bone disease (75089). A meta-analysis suggests that the risk of rheumatoid arthritis is elevated with occupational exposure to silicon dioxide (75078).
Neurologic/CNS ...High silicon levels in patients undergoing chronic hemodialysis have been associated with neuropathy (75089).
Pulmonary/Respiratory ...Occupational exposure to crystalline silicon dioxide dust is associated with an increased risk of pulmonary diseases such as silicosis, tuberculosis, chronic bronchitis, chronic obstructive pulmonary disease (COPD), and lung cancer (75076,75081,75084,75114). Patients with occupational pulmonary silicosis may develop microscopic polyangiitis (inflammation of the blood vessels in the nose, sinuses, throat, lungs, and kidneys, also known as Wegener's granulomatosis). Meta-analyses suggest that occupational exposure to silicon dioxide increases the risk of lung cancer (75085,75095,75115). An analysis of 19 studies shows that lung cancer risk is approximately 2 times higher for those with silicosis (75115). It is not clear whether silicon dioxide is carcinogenic in the absence of silicosis (75083).
