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Proprietary Probiotic Blend
(60 Billion CFU, formulated with 60 billion CFU at time of manufacturing)
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(Lactobacillus acidophilus )
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(Lactobacillus plantarum )
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(Lactobacillus rhamnosus )
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(Lactobacillus salivarius )
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(Lactobacillus paracasei )
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(Streptococcus thermophilus )
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(Lactobacillus casei )
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(Lactobacillus bulgaricus )
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(Bifidobacterium animalis lactis )
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Lactobacillus brevis
(Lactobacillus brevis )
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(Bifidobacterium longum )
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(FOS)
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Cellulose, Ascorbyl Palmitate, Microcrystalline Cellulose
Below is general information about the effectiveness of the known ingredients contained in the product BioDophilus60. 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
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 BioDophilus60. 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 longum has been safely used alone or in combination with other probiotics in clinical trials lasting up to one year (1233,12108,13054,14334,35382,35403,35424,103440,103446,105129)(107593,110968,110972,111773,111776,111847,111851,111854,111857,111858).
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
Bifidobacterium longum has been safely used alone or in combination with other probiotics in infants and children for up to 4 months (3162,35377,35383,35393,35406,35407,92266,98736,107531,110924)(110976,111001,111015,111825,111833,111848). There is insufficient reliable information available about the safety of B. longum in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given these 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 AND LACTATION: POSSIBLY SAFE
when used orally and appropriately, short-term.
A combination of Bifidobacterium longum and Lacticaseibacillus rhamnosus has been used with apparent safety throughout pregnancy (105128,105144). A combination of B. longum BB536 and Bifidobacterium breve M-16V has been used with apparent safety from about 4 weeks before the expected due date until delivery (111015). Also, a combination of B. longum and Lacticaseibacillus paracasei has been used with apparent safety from 2 months prior to delivery until 2 months after delivery during lactation (90285).
POSSIBLY SAFE ...when used orally and appropriately, alone or in combination with probiotics, in doses up to 30 grams daily for up to 4 weeks (741,745,8505,90266,107729,107931). ...when a specific FOS product (NutraFlora, Ingredion Inc.) is used orally in combination with calcium at doses up to 3.2 grams daily for up to 24 months (94931).
CHILDREN: POSSIBLY SAFE
when short-chain FOS are included in approved infant formulas for healthy term infants at a level of up to 4 grams/L or 1 gram/kg daily (94929,94930,98651).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately. Lacticaseibacillus casei has been safely used alone or in combination with other ingredients in studies lasting up to 8 weeks (90230,112517).
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
Lacticaseibacillus casei has been safely used alone in studies lasting up to 4 months (14373,107544). Also, a specific mixture (Latopic, Biomed S.A.) providing 1 billion CFUs of L. casei ŁOCK 0919 50%, Lacticaseibacillus rhamnosus ŁOCK 0900 25%, and L. rhamnosus ŁOCK 0908 25% has been used with apparent safety for 3 months in children under 2 years of age (107510). In addition, in children ages 4-17 years, a 1:1:1 combination of L. casei CECT 9104, Bifidobacterium animalis subsp. lactis CECT 8145, and Bifidobacterium longum CECT 7347 providing 1 billion CFUs has been used with apparent safety for 12 weeks (107531). There is insufficient reliable information available about the safety of L. casei 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 Lacticaseibacillus casei, Lactobacillus acidophilus, 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 Lacticaseibacillus casei during 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. 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).
LIKELY SAFE ...when live Lactiplantibacillus plantarum is used orally and appropriately. L. plantarum has been safely used alone or in combination with other probiotics in studies lasting up to 9 months (6087,14370,14371,90255,105136,107515,107552,107555,107557,107559)(110961,111963,111966,111973,111976,111979,111983,111986,111990,111994).
POSSIBLY SAFE ...when heat-killed Lactiplantibacillus plantarum is used orally and appropriately. Non-viable L. plantarum strains have been safely used in doses of 50 mg daily for 4 weeks, 10 mg daily for up to 12 months, or up to 300 billion cells daily for up to 12 weeks (107530,111985,111988,111995). ...when L. plantarum is used intravaginally and appropriately. L. plantarum P17630 has been used with apparent safety daily for 6 days, then weekly for 16 weeks (98435). Also, L. plantarum 57B has been used with apparent safety along with Limosilactobacillus fermentum and Lactobacillus gasseri as part of a specific product (InVag) for up to 7 days (111961).
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
Lactiplantibacillus plantarum has been safely used in children aged 7-15 years for up to 4 weeks (107540), in healthy newborns for 7 days (111989), and in children up to age 5 years for up to 90 days (111975,111981,111982). Also, L. plantarum has been used safely as a component of a combination probiotic product (Visbiome, ExeGi Pharma) in children aged 2-12 years for up to 3 months (107497) or in combination with Lacticaseibacillus paracasei for up to 12 weeks (107556). There is insufficient reliable information available about the safety of L. plantarum 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.
Lactiplantibacillus plantarum (Lp299v, DSM 9843) has been used with apparent safety in doses of 10 billion colony-forming units (CFUs) daily in combination with iron, ascorbic acid, and folic acid daily from 10-12 weeks' gestation until delivery (107550).
LACTATION:
There is insufficient reliable information available about the safety of Lactiplantibacillus plantarum during lactation.
However, there are currently no reasons to expect safety concerns when used appropriately.
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.
POSSIBLY SAFE ...when used orally. In the United States, most yogurt is made via bacterial fermentation with Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (12778). Probiotic species similar to L. delbrueckii have not been associated with serious safety concerns when used appropriately in healthy adults. Most clinical trials have used L. delbrueckii in combination with other probiotics. It is unclear which specific dose and duration of use for L. delbrueckii as a probiotic may be most appropriate.
CHILDREN:
There is insufficient reliable information available about the safety of Lactobacillus delbrueckii as a probiotic in children of any age.
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:
There is insufficient reliable information available about the safety of Lactobacillus delbrueckii during pregnancy and lactation.
However, there are currently no reasons to expect safety concerns when used appropriately.
LIKELY SAFE ...when used orally and appropriately. Streptococcus thermophilus in combination with other probiotic strains has been safely used in clinical trials lasting up to one year (162,1233,1731,3261,6087,11379,12769,14370,14371,16740,102440).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately.
Streptococcus thermophilus in combination with other probiotic species has been used with apparent safety in children of most ages for up to one year (161,3169,16841,90241,102426,102436,111106). There is insufficient reliable information available about the safety of Streptococcus thermophilus 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, short-term.
A combination of Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium animalis, and Lactobacillus delbrueckii has been used with apparent safety for 8 weeks starting at 24-28 weeks gestation (96892).
LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product BioDophilus60. 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 longum with antibiotic drugs might decrease the effectiveness of B. longum.
Details
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Theoretically, taking Lacticaseibacillus casei with antibiotic drugs might decrease the effectiveness of L. casei.
Details
L. casei 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. casei preparations by at least two hours.
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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 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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Theoretically, taking Lactiplantibacillus plantarum with antibiotic drugs might decrease the effectiveness of L. plantarum.
Details
L. plantarum 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. plantarum 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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Theoretically, taking Lactobacillus delbrueckii with antibiotic drugs might decrease the effectiveness of L. delbrueckii.
Details
Lactobacillus delbrueckii 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. delbrueckii 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 BioDophilus60. 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 longum seems to be well tolerated by most patients.
Serious Adverse Effects (Rare):
Orally: There is concern that B. longum may cause bacteremia in certain patients.
Gastrointestinal ...When taken orally, abdominal discomfort, pain, and distension have been reported rarely (111773,111847,111856). Flatulence has been reported rarely with Bifidobacterium longum when used alone or in combination with other species of probiotics (107520,111773). Other rare gastrointestinal side effects have included constipation and gastrointestinal motor disorder (111773).
Immunologic ...There have been rare cases of Bifidobacterium bacteremia in critically ill infant and adult patients (102416,107599). Various cases of Bifidobacterium longum bacteremia, sometimes presenting as sepsis, have occurred in preterm infants using probiotics (102416,111610,111612,111850,111852,111853). In one case report, a 15-month-old female infant with congenital heart defects and recent surgery to replace a mechanical heart valve developed Bifidobacterium sepsis after being treated with IV antibiotics, extracorporeal membrane oxygenation (ECMO), and oral probiotics containing B. longum. It was thought that ECMO contributed to translocation of bifidobacteria from the gut and into the blood (102416). In 5 cases, very-low birthweight preterm infants developed B. longum bacteremia following the use of a specific probiotic product providing B. longum and Lactobacillus acidophilus (Infloran) for the prevention of necrotizing enterocolitis; antibiotic treatment was required in at least some of the cases (111850,111852,111853). Cases of sepsis related to B. longum have also occurred in adults; however, association with supplementation is unlikely. In one case, sepsis with B. longum occurred following acupuncture. This was likely due to needle contamination and not to supplementation (1236). In another case, a 71-year-old male with liver cirrhosis and prostate cancer developed B. longum lumbar vertebrodiscitis. The source was thought to be translocation from the intestine (111859). A 42-year-old male developed B. longum peritonitis secondary to intestinal perforation (111855).
Pulmonary/Respiratory ...When taken orally, a dry cough has been reported by a single patient in a clinical trial (111851).
Other ...When taken orally, weight gain has been reported by a single patient in a clinical trial (111773).
General
...Orally, FOS are generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, bloating, flatulence.
Gastrointestinal ...Orally, FOS may cause flatulence, belching, abdominal pain, intestinal sounds, constipation, and bloating. These symptoms can occur commonly in some patients, but are generally mild at doses under 10 grams per day (745,750,8509,98651,107931). However, a meta-analysis of 8 small clinical studies shows that taking FOS at doses ranging from 2.5 grams to 15 grams daily for up to 8 weeks does not increase the rate of abdominal pain, bloating, flatulence, or intestinal sounds when compared with control groups (110710).
General
...Orally, Lacticaseibacillus casei is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that lactobacilli may cause infections in some people.
Gastrointestinal ...Orally, taking Lacticaseibacillus casei in combination with other probiotics may cause gastrointestinal side effects including abdominal pain (90291); however, these events are uncommon.
Immunologic
...Since Lacticaseibacillus casei preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients.
Some lactobacilli species have been isolated in some cases of bacteremia, sepsis, splenic abscess, endocarditis, aortic dissection, 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. The majority of cases are not related to the use of probiotic supplements and most are not associated with the use of L. casei (107543,112516). There is at least one case of L. casei bacteremia and endocarditis thought to be related with L. casei intake in a 71-year-old immunocompromised female (112520).
There are two cases of L. casei infection in a prosthetic joint (90282,112514). In one case, the 95-year-old female with a history of hypertension, diabetes, and heart disease was known to consume yogurt containing L. casei. However, it was not confirmed that the infection was related to the consumption of this product. Spread from the gastrointestinal tract or vaginal flora could not be ruled out (90282). In the case of an 80-year-old male, the cause was unknown as there was no probiotic supplementation and no underlying medical condition or infectious portal of entry (112514).
A specific probiotic preparation (NBL probiotic ATP, Nobel) containing L. casei, Lacticaseibacillus rhamnosus, 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).
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, 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).
General
...Orally and intravaginally, Lactiplantibacillus plantarum is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that L. plantarum may cause infections in some people.
Gastrointestinal ...Orally, taking Lactiplantibacillus plantarum may cause gastrointestinal side effects including diarrhea, loose stools, nausea, stomach pain, rumbling, bloating, and flatulence (90271,107497,107556,107557,112064,111993); however, these events are uncommon.
Immunologic
...Since Lactiplantibacillus plantarum preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients.
Lactobacilli species, including L. plantarum, have been isolated in some cases of bacteremia, sepsis, splenic abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, and meningoencephalitis. Most cases of L. plantarum infection 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). However, there are also rare case reports of pathogenic infections possibly related to intake of L. plantarum supplements in these populations. In one case report, the diagnosis of L. plantarum bacteremia in a regular consumer of the fermented food Nukazuk was thought to be related to the eventual diagnosis of rectal cancer (107551).
A specific probiotic preparation (NBL probiotic ATP, Nobel) containing L. plantarum, Lacticaseibacillus casei, Lacticaseibacillus rhamnosus, 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).
Neurologic/CNS ...Orally, use of Lactiplantibacillus plantarum 299v 10 billion colony-forming units daily has been associated with one case of transient vertigo in one clinical trial (90249).
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, Lactobacillus delbrueckii seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: There is concern that Lactobacillus delbrueckii may cause infections in some people.
Immunologic
...Since Lactobacillus delbrueckii preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients.
Some lactobacilli species have been isolated in cases of bacteremia, sepsis, splenic abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, and meningoencephalitis. 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, or the gastrointestinal or urogenital tract, and not to dietary or supplemental intake (107543,110917,110918,110920,110921).
There are various cases of L. delbrueckii urinary tract infections (UTI) (112553,112557,112558). In one case, a L. delbrueckii UTI occurred in an 82-year-old male with benign prostate hyperplasia and related urinary retention (112553). Any use of probiotic products containing L. delbrueckii was not mentioned in this report. In one case, a 49-year-old male with a L. delbrueckii UTI reported daily yogurt intake, possibly fermented with L. delbrueckii. He had urinary retention in the absence of benign prostate hypertrophy and initially presented with acute bacterial prostatitis (112557). Most cases of UTIs have occurred in older females. An 85-year-old female with recurrent UTIs denied probiotic use; however, exposure via ingested foods was possible (112558).
General
...Streptococcus thermophilus is well tolerated.
Serious adverse effects have not been reported in clinical research.
Serious Adverse Effects (Rare):
Orally: There is concern that probiotics may cause infections in some people.
Immunologic ...Since many probiotic preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. Bacteremia and sepsis have been reported in patients with indwelling or central venous catheters or patients who are severely ill and/or immunocompromised, including preterm infants, that were using probiotic products (4380,8561,13008,13070,90298,102416,103444,105138,105140,105141)(107543,107597,107599,111610,111612,111613,111850,111852,111853). However, reports of pathogenic colonization in relatively healthy patients with intact immune systems who do not have indwelling or central venous catheters are extremely rare (4380,4389,4390,4391,4393,4398,105139,107543,107545,107546)(107547).
