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Published on: January 27, 2019
Safety of Bifidobacterium breve (BBG-01) in preterm infants
Hiroyuki Kitajima1, Shinya Hirano1
1Department of Neonatal Medicine, Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi, Osaka, Japan.
Insights
Adverse events from Bifidobacterium breve (BBG-01) are rare and mild. This probiotic preparation demonstrates superior safety in pediatric patients, including those with diarrhea and preterm infants.
Area of Science:
- Microbiology
- Pediatric Medicine
- Clinical Pharmacy
Background:
- Viable cells of Bifidobacterium breve (BBG-01) have been utilized in pediatric care since 1982 for conditions like intractable infantile diarrhea, preterm status, and post-pediatric surgery.
- While BBG-01's efficacy is well-documented, reports of adverse events are exceptionally infrequent.
Purpose of the Study:
- To investigate and document adverse events associated with Bifidobacterium breve (BBG-01) usage in clinical settings.
- To assess the safety profile of BBG-01 based on reported occurrences and clinical details.
Main Methods:
- A questionnaire survey was distributed to 109 physicians across 88 medical institutions where BBG-01 was administered.
- The survey collected data on the frequency and specific details of any observed adverse events.
Main Results:
- A response rate of 78.9% was achieved, with 86 clinicians from 70 institutions providing data.
- The majority of BBG-01 treated patients (over 90%, totaling 23,092) were in pediatrics and premature/newborn medicine, primarily preterm infants and those with intractable diarrhea.
- Four adverse events were reported: two cases of functional ileus in extremely premature infants due to starch aggregates, and two cases of bacteremia in surgical neonates caused by B. breve genetically identical to BBG-01. No severe adverse events with poor outcomes were noted.
Conclusions:
- Adverse events linked to Bifidobacterium breve (BBG-01) administration occur with extremely low frequency.
- The reported adverse events were mild in severity, underscoring the excellent safety profile of the BBG-01 preparation.
Background:
Since 1982, viable cells of Bifidobacterium breve (BBG-01) have been used in pediatric patients for clinical conditions such as intractable infantile diarrhea, preterm status, and pediatric surgery. Although the efficacy of BBG-01 has been widely reported, adverse events related to the use of BBG-01 have been reported in very few cases.
Methods:
In order to trace adverse events seen by 109 doctors in 88 medical institutions where BBG-01 was used, a questionnaire survey of the number of occurrences and details of each case was conducted.
Results:
Eighty-six clinicians (70 institutions) responded to the questionnaire (response rate, 78.9%). Number of respondents according to department of diagnosis (no. BBG-01-treated infants) was as follows: pediatrics, 29 respondents (10 938 patients); premature and newborn medicine, 26 (10 677 patients); obstetrics and gynecology, 1 (1212 patients) and pediatric surgery, 22 (169 patients). More than 90% of the total BBG-01-treated patients (23 092 patients) were in the departments of premature and newborn medicine and pediatrics, and BBG-01 had been used mainly in preterm infants and children with intractable diarrhea. Adverse events occurred in two extremely premature infants with functional ileus due to starch aggregates as vehicle, and in two surgical neonates with bacteremia caused by B. breve genetically identical to BBG-01, and no serious adverse events with poor outcome were reported.
Conclusion:
Adverse events related to the use of BBG-01 have an extremely low incidence and are mild in severity, thus ensuring the superior safety of this preparation.
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