| Ingredients | Each Capsule Contains |
|---|---|
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(Lactobacillus paracasei LP-33 )
(5 billion CFU)
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(Bifidobacterium longum BB536 )
(3 billion CFU)
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(Lactobacillus fermentum GMNL-93 )
(2 billion CFU)
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(Bifidobacterium breve M16V )
(1 billion CFU)
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(Lactobacillus rhamnosus GG )
(20 billion CFU)
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Below is general information about the effectiveness of the known ingredients contained in the product AllerG Biotic. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product AllerG Biotic. 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 breve has been safely used alone or in combination with other probiotics in clinical trials lasting up to one year (3261,6087,11379,12769,12775,14338,14370,14371,103447,111002)(111003,111005).
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
Bifidobacterium breve has been safely used alone or in combination with other probiotics in infants and children for up to 12 months (17726,35377,92256,103449,105150,105151,107497,107598,111001)(111004,111008,111015). Cases of bacteremia have occurred rarely in children (107597). There is insufficient reliable information available about the safety of B. breve in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given B. breve or other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of Bifidobacterium breve during pregnancy or lactation.
However, there are currently no reasons to expect safety concerns when used appropriately.
LIKELY SAFE ...when 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).
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).
POSSIBLY SAFE ...when used orally and appropriately. Limosilactobacillus fermentum has been safely used alone and in combination with other probiotics in studies lasting up to 12 weeks (112503,112562,112570). ... when used intravaginally and appropriately. L. fermentum has been used safely daily for up to 7 days and biweekly and/or monthly in studies lasting up to 10 weeks (6095,111961).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately in children of most ages.
Limosilactobacillus fermentum has been safely used alone and in combination with other probiotics in studies lasting up to 6 months (98440,105150,112569,112573,112574). There is insufficient reliable information available about the safety of L. fermentum 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:
There is insufficient reliable information available about the safety of Limosilactobacillus fermentum during pregnancy.
However, there are currently no reasons to expect safety concerns when used appropriately.
LACTATION: POSSIBLY SAFE
when used orally and appropriately.
Limosilactobacillus fermentum CECT5716 has been used with apparent safety when breastfeeding for up to 16 weeks (112566).
Below is general information about the interactions of the known ingredients contained in the product AllerG Biotic. 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 breve with antibiotic drugs might decrease the effectiveness of B. breve.
 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 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 Limosilactobacillus fermentum with antibiotic drugs might decrease the effectiveness of L. fermentum.
Details
Limosilactobacillus fermentum 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. fermentum 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 AllerG Biotic. 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 breve seems to be well tolerated by most patients.
Serious Adverse Effects (Rare):
Orally: There is concern that B. breve may cause bacteremia in certain patients.
Gastrointestinal ...Bloating and flatulence have been reported with probiotic use; however, these adverse effects have not been reported from ingestion of Bifidobacterium breve in particular.
Immunologic
...There have been rare cases of Bifidobacterium bacteremia related to probiotic use in critically ill infants and adults (102416,107597,107599).
In addition, cases of B. breve bacteremia have occurred in preterm infants or young children using probiotics (102416,107597). In a review of 298 term and preterm infants who were admitted to the neonatal intensive care unit of a hospital in Japan and received B. breve BBG-01 over a five-year period, bacteremia occurred in six patients (2%). Concomitant conditions included gastrointestinal perforation, food-induced enterocolitis syndrome, adhesive ileus, ileal volvulus, and aspiration pneumonia following esophageal atresia repair (107597). In one case report, B. breve BBG-01 was provided to an infant starting two days after birth and the day of surgery for an omphalocele. The infant also had bilious gastric fluid with elevated inflammatory markers. It is thought that the intestinal surgical repair might have led to the translocation of the ingested B. breve (107596).
Some cases of B. breve bacteremia do not seem to be directly related to probiotic use. There have been rare cases of B. breve bacteremia and necrotizing fasciitis in patients with type 2 diabetes. One patient had pre-existing chronic diabetic foot ulcers and the other had abscesses near the groin (111007,111011). A childhood history of frequent consumption of fermented beverages containing B. breve was thought to have resulted in B. breve in the intestinal flora of one of these patients, aged 42 years (111011). However, it is unclear if consumption of an unknown quantity of B. breve more than 20 years previously would play a role in this outcome. There is also a rare case of ventriculoperitoneal shunt B. breve infection possibly related to poor oral hygiene and dentition (111014).
General
...Orally, 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, 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, Limosilactobacillus fermentum seems to be well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that Limosilactobacillus fermentum may cause infections in some people.
Gastrointestinal ...Orally, taking Limosilactobacillus fermentum may cause mild gastrointestinal side effects (112564).
Genitourinary ...Vaginal burning was reported by one person using intravaginal Limosilactobacillus fermentum and Lactobacillus acidophilus in a clinical trial (111781).
Immunologic ...Since Limosilactobacillus fermentum 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 specific examples of L. fermentum infections, including endocarditis, brain abscess, surgical site (esophagus) abscess, peritonitis, and abdominal sepsis leading to emphysematous gastritis (107543,112565,112571,112576,112577,112578).
