Active Bacterial Cultures of Lactobacillus acidophilus (CL1285) and Lactobacillus casei (Lbc80r) • Whey Protein Concentrate. Other Ingredients: Skim Milk Powder, Water, Evaporated Cane Juice, Citrus Fiber, Natural Flavours (pineapple, vanilla).
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Below is general information about the effectiveness of the known ingredients contained in the product Bio-K+ CL1285 Fruity Flavor. 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 Bio-K+ CL1285 Fruity Flavor. 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. 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 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. Whey protein up to 30 grams has been safely used in clinical trials for up to 6 months (4930,16728,16729,105587).
CHILDREN: LIKELY SAFE
when used orally and appropriately as a dietary protein in food or infant formula.
Hydrolyzed whey protein-based formula has been safely used in infants for up to 6 months in clinical trials (4927,105585,105594).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Bio-K+ CL1285 Fruity Flavor. 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 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 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, whey protein might reduce the absorption of bisphosphonates.
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Theoretically, whey protein might decrease levodopa absorption.
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Theoretically, whey protein might decrease quinolone absorption.
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Theoretically, whey protein might decrease tetracycline absorption.
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Below is general information about the adverse effects of the known ingredients contained in the product Bio-K+ CL1285 Fruity Flavor. 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, 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 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, whey protein is generally well tolerated.
Most Common Adverse Effects:
Orally: Acne, bloating, cramps, diarrhea, fatigue, headache, nausea, reflux, reduced appetite, and thirst. Most adverse effects are dose-related.
Cardiovascular ...In one case report, use of an unclear quantity of whey protein over one month was thought to be probably responsible for the development of coronary embolism in three coronary arteries in a 33-year-old male with no history of atherosclerosis risk factors. The patient required treatment with intravenous glycoprotein IIb/IIIa inhibitor and heparin (96023).
Dermatologic ...Orally, whey protein has been reported to trigger the onset or worsening of acne. Multiple case reports in teenagers and young adults have associated intake of whey protein with the development of acne or the worsening of existing acneiform lesions. In these reports, the discontinuation of whey protein was typically associated with the clearance of acne lesions. In some cases, patients who were unresponsive to acne treatments while using whey protein became responsive after whey protein discontinuation (103965,103970,103971). Cow's milk, which is comprised of 20% whey protein, is also thought to exacerbate acne. It is theorized that this effect may be due to the growth factor and alpha-lactalbumin content of whey protein (103971,103982).
Gastrointestinal ...Orally, whey protein, especially in higher doses of 2. 3-6.5 grams/kg daily, may cause increased bowel movements, nausea, thirst, bloating, esophageal reflux, cramps, and reduced appetite (2640,85961,85702,86043,86074,86075,86084,86089,86095).
Hepatic ...In two case reports, acute cholestatic liver injury occurred after consumption of the combination of whey protein and creatine supplements (46701,90319).
Musculoskeletal ...In one case report, a 26-year-old male experienced fasciitis, or swelling of the forearms, hands, and legs, after consuming the supplement Pure Whey (85895).
Neurologic/CNS ...Orally, high doses of whey protein may cause tiredness or fatigue and headache (2640). Mild drowsiness has also been reported (86089,86092,86124).
