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Background <p>Weaning involves rapid shifts in the gut microbiota, bowel irregularities, and increased infection risks. This exploratory, hypothesis-generating study examined whether daily supplementation with <i>Bifidobacterium longum</i> subsp. <i>infantis</i> M-63 (M-63) may influence bowel function, the gut environment, and general health during weaning.</p> Methods <p>In a randomized, double-blind, placebo-controlled trial, 100 healthy infants and toddlers (5 months to under 3 years) received M-63 (5 billion CFU) or placebo for eight weeks. Stool habits, fecal microbiota, and short-chain fatty acids (SCFAs) were assessed. Cold-like symptoms and medication use were recorded. Exploratory subgroup analyses considered breastfeeding status, age (&lt;1.5 years), and the presence of siblings.</p> Results <p>M-63 supplementation was associated with more days of normal stools and a trend toward fewer diarrhea episodes. Subgroup analyses revealed that breastfed children showed increased <i>B. infantis</i> abundance. In contrast, non-breastfed children exhibited higher fecal SCFA levels. Children &lt;1.5 years and those with siblings showed trends toward fewer cold-like symptoms and reduced antibiotic use. No intervention-related adverse events occurred.</p> Conclusions <p>This exploratory trial suggests M-63 may be associated with modest improvements in gastrointestinal outcomes and selected systemic health-related measures during weaning. These findings should be interpreted cautiously and require confirmation in adequately powered trials.</p> Impact <p><UnorderedList Mark="Bullet"> <ItemContent> <p>Daily administration of <i>B. infantis</i> M-63 was associated with potential improvements in bowel habits among infants.</p> </ItemContent> <ItemContent> <p>In breastfed children, supplementation with <i>B. infantis</i> M-63 was associated with an observed increase in the relative abundance of <i>B. infantis</i>, alongside a trend toward greater bifidobacterial diversity.</p> </ItemContent> <ItemContent> <p>In non-breastfed children, <i>B. infantis</i> M-63 was associated with modestly elevated levels of fecal metabolites, including short-chain fatty acids.</p> </ItemContent> <ItemContent> <p>Exploratory findings suggest that supplementation with <i>B. infantis</i> M-63 during weaning may modulate the gut environment and may be associated with immune-related measures, but confirmation in larger, rigorously designed trials is needed.</p> </ItemContent> </UnorderedList></p>

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Effects of Bifidobacterium infantis M-63 on gut environment and bowel function during weaning: RCT

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月29日

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  • Satoshi Arai,
  • Akari Hiraku,
  • Setsuko Nakata,
  • Kazuya Toda,
  • Atsuyuki Odani,
  • Eri Mitsuyama,
  • Riko Mishima,
  • Toshitaka Odamaki,
  • Noriyuki Iwabuchi,
  • Miyuki Tanaka

摘要

Background

Weaning involves rapid shifts in the gut microbiota, bowel irregularities, and increased infection risks. This exploratory, hypothesis-generating study examined whether daily supplementation with Bifidobacterium longum subsp. infantis M-63 (M-63) may influence bowel function, the gut environment, and general health during weaning.

Methods

In a randomized, double-blind, placebo-controlled trial, 100 healthy infants and toddlers (5 months to under 3 years) received M-63 (5 billion CFU) or placebo for eight weeks. Stool habits, fecal microbiota, and short-chain fatty acids (SCFAs) were assessed. Cold-like symptoms and medication use were recorded. Exploratory subgroup analyses considered breastfeeding status, age (<1.5 years), and the presence of siblings.

Results

M-63 supplementation was associated with more days of normal stools and a trend toward fewer diarrhea episodes. Subgroup analyses revealed that breastfed children showed increased B. infantis abundance. In contrast, non-breastfed children exhibited higher fecal SCFA levels. Children <1.5 years and those with siblings showed trends toward fewer cold-like symptoms and reduced antibiotic use. No intervention-related adverse events occurred.

Conclusions

This exploratory trial suggests M-63 may be associated with modest improvements in gastrointestinal outcomes and selected systemic health-related measures during weaning. These findings should be interpreted cautiously and require confirmation in adequately powered trials.

Impact

Daily administration of B. infantis M-63 was associated with potential improvements in bowel habits among infants.

In breastfed children, supplementation with B. infantis M-63 was associated with an observed increase in the relative abundance of B. infantis, alongside a trend toward greater bifidobacterial diversity.

In non-breastfed children, B. infantis M-63 was associated with modestly elevated levels of fecal metabolites, including short-chain fatty acids.

Exploratory findings suggest that supplementation with B. infantis M-63 during weaning may modulate the gut environment and may be associated with immune-related measures, but confirmation in larger, rigorously designed trials is needed.