Each capsule contains: 1,3-(1-3,1-4)-Beta-D-Glucan 3(4)-Glucanohydrolase (3.6 FCC BGU) 1.03 mg • 1,4-Alpha-D-Glucan Glucanohydrolase (4 FCC AGU) 5.25 mg • 4-(1,3;1,4)-Beta-D-Glucan 4-Glucanohydrolase (170 FCC CU) 1 mg • 4-Alpha-D-Glucan Glucanohydrolase (2250 FCC DU) 19 mg • Bifidobacterium bifidum 500 million CFU • Bifidobacterium longum subsp. infantis 500 million CFU • Bifidobacterium longum subsp. longum 250 million CFU • Fructooligosaccharides 100 mg • Lactobacillus acidophilus 5 billion CFU • Lactobacillus brevis 250 million CFU • Lactobacillus casei 250 million CFU • Lactobacillus delbrueckii subsp. bulgaricus 250 million CFU • Lactobacillus delbrueckii subsp. delbrueckii 250 million CFU • Lactobacillus plantarum 500 million CFU • Lactobacillus salivarius 500 million CFU • Diastase (250 FCC DP) 3.1 mg • Poly(alpha-1,4-galacturonide) Glycanohydrolase (4 Endo-PG) 2.67 mg • Protease 6.0 (710 FCC HUT) 1.4 mg • Streptococcus salivarius subsp. thermophilus 1.75 million CFU • Triacylglycerol Lipase (55 FCC LU) 2.8 mg • Triacylglycerol Lipase (40 FCC LU) 2 mg • Alpha-L-Arabinofuranoside Arabinofuranohydrolase (273FCC HCU) 0.55 mg • Alpha-L-Arabinofuranoside Arabinofuranohydrolase Orthophosphoric-monoester phosphohydrolase (03675 FCC FTU) 0.45 mg. Other Ingredients: Gelatin, Maltodextrin, Mineral Oil.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
Below is general information about the effectiveness of the known ingredients contained in the product Probiotx 11. 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
Proteolytic enzymes represent a wide group of enzymes that are used alone or in combination. See specific monographs for effectiveness information.
Below is general information about the safety of the known ingredients contained in the product Probiotx 11. 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. 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 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 and appropriately. Various proteolytic enzymes have been safely used orally in clinical research (716,964,965,968,969,6252,6253,10622,11457,18281,18284) (91104,91105,91106,91111,96449). Side effects are typically mild to moderate and most often include gastrointestinal effects. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes. ...when used topically and appropriately. Various proteolytic enzymes have been safely used topically in clinical research (67835,67843,67845,91113). Some proteolytic enzymes might cause allergic reactions when used topically. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Probiotx 11. 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 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 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 Probiotx 11. 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, 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 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, proteolytic enzymes are generally well tolerated.
See specific monographs for detailed safety information related to individual proteolytic enzymes.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Serious Adverse Effects (Rare):
Topically: Allergic reactions.
Gastrointestinal ...Orally, some patients taking proteolytic enzymes may have gastrointestinal complaints (101517).
Immunologic ...Proteolytic enzymes are commonly found in laundry detergents and pre-spotter products. Rarely, protease specific IgE positive tests possibly related to these products have occurred. Exposure may be airborne or topical (102705). In addition, in case reports, occupational exposure to the airborne proteolytic enzyme pepsin has resulted in allergic rhinoconjunctivitis or asthma (102706,102707).
