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Effects of Bifidobacterium infantis M-63 on gut environment and bowel function during weaning: RCT
Satoshi Arai1, Akari Hiraku2, Setsuko Nakata3
1Biotics Research Institute, R&D Division, Morinaga Milk Industry Co. Ltd., Zama, Japan. s-arai@morinagamilk.co.jp.
Pediatric Research
|April 29, 2026
Summary
Daily Bifidobacterium longum subsp. infantis M-63 (M-63) supplementation may improve infant bowel regularity during weaning. It also showed potential benefits for gut microbiota and immune health, particularly in breastfed infants, warranting further research.
Area of Science:
- Pediatric Nutrition
- Gut Microbiome Research
- Probiotic Applications
Background:
- Weaning presents challenges like gut dysbiosis, irregular bowel movements, and increased infection susceptibility.
- The gut microbiota undergoes significant changes during this transition period.
- Exploring interventions to support infant health during weaning is crucial.
Purpose of the Study:
- To investigate the effects of daily Bifidobacterium longum subsp. infantis M-63 (M-63) supplementation on infant bowel function.
- To assess the impact of M-63 on the gut environment, including microbiota and short-chain fatty acids (SCFAs).
- To explore potential influences on general health measures, such as infection risk, during the weaning period.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 100 healthy infants and toddlers (5 months to <3 years).
- Participants received either M-63 (5 billion CFU) or a placebo for eight weeks.
- Outcomes assessed included stool habits, fecal microbiota composition, SCFA levels, and recording of cold-like symptoms and medication use.
Main Results:
- M-63 supplementation was linked to more days of normal stools and a trend towards fewer diarrhea episodes.
- In breastfed infants, M-63 increased Bifidobacterium infantis abundance and showed a trend towards greater bifidobacterial diversity.
- Non-breastfed infants showed higher fecal SCFA levels with M-63. Trends towards fewer cold-like symptoms and reduced antibiotic use were observed in younger infants (<1.5 years) and those with siblings.
Conclusions:
- Daily M-63 supplementation may offer modest benefits for gastrointestinal outcomes in infants during weaning.
- The probiotic appears to modulate the gut environment differently in breastfed versus non-breastfed infants.
- Further large-scale, rigorous trials are necessary to confirm these exploratory findings and their clinical significance.
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