Each chewable wafer contains: LB-51 strain Lactobacillus bulgaricus 1 billion CFU.
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Below is general information about the effectiveness of the known ingredients contained in the product Healthy Tummy. 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
Below is general information about the safety of the known ingredients contained in the product Healthy Tummy. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
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.
Below is general information about the interactions of the known ingredients contained in the product Healthy Tummy. 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 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 Healthy Tummy. 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, 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).