| Ingredients | Amount Per Serving |
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Live Probiotics
(4 billion CFUs)
(Live Probiotics Note: 4 billion CFUs )
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(Lactobacillus acidophilus )
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(L. plantarum )
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(L. bulgaricus )
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(B. bifidum )
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(S. thermophilus )
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Inulin, DRcaps Vegetable Capsule (Form: Gellan PlantPart: gum, Hypromellose), Magnesium Stearate, Silicon Dioxide (Alt. Name: SiO2), Microcrystalline Cellulose
Below is general information about the effectiveness of the known ingredients contained in the product Probiotic Complex. 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
Below is general information about the safety of the known ingredients contained in the product Probiotic Complex. 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 bifidum has been safely used alone or in combination with other probiotics in clinical trials lasting up to one year (1731,12775,14338,92255,107580,110972,110974,110978). There is insufficient reliable information available about the safety of non-viable, heat-killed B. bifidum formulations when used orally.
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
Bifidobacterium bifidum has been safely used alone or in combination with other probiotics in clinical trials in infants and children for up to 18 months (161,90286,90602,98736,103436,110971,110976,110924). There is insufficient reliable information available about the safety of B. bifidum 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 Bifidobacterium bifidum is used orally and appropriately, short-term.
A combination of B. bifidum, Lactobacillus acidophilus, and Lacticaseibacillus casei 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 Bifidobacterium bifidum 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.
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 Probiotic Complex. 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. bifidum with antibiotic drugs might decrease the effectiveness of B. bifidum.
 Details
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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 Probiotic Complex. 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 bifidum seems to be well tolerated by most patients.
Serious Adverse Effects (Rare):
Orally: There is concern that probiotics may cause infections in some people.
Gastrointestinal ...Bloating and flatulence have been reported with probiotic use; however, these adverse effects have not been reported from ingestion of Bifidobacterium bifidum in particular. One case of vomiting and fever has been reported in a clinical study for a single child taking B. bifidum and Lactobacillus acidophilus. It is unclear if the probiotics were the causal agent (90286).
Immunologic ...There have been cases of Bifidobacterium sepsis in critically ill patients (102416,107599). However, these cases are rare and none seem to be due to Bifidobacterium bifidum.
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
...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).
