Anti-inflammatory effects of Bifidobacterium infantis M-63 during the early postnatal period in term infants.
- 2025-07-18
- Pediatric research 99(5)
- Chendong Xu
- Toshitaka Odamaki
- Akari Hiraku
- Setsuko Nakata
- Satoshi Arai
- Noriyuki Iwabuchi
- Miyuki Tanaka
- Takahisa Tsuno
- Masahiko Nakamura
- PubMed: 40681696
- DOI: 10.1038/s41390-025-04263-y
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- 111 healthy infants
- Methods
- Randomized, placebo-controlled trial; daily dose of 1.0×10^9 CFU B. infantis M-63 or placebo from 7 days to 3 months of age
- Duration
- from 7 days to 3 months of age
- Funding
- Unclear
Background
The administration of Bifidobacterium infantis M-63 during the early postnatal period enhances the abundance of gut Bifidobacterium, but its potential effects are still unexplored. The present study aimed to evaluate the impact of B. infantis M-63 on immunity, inflammation, gut-derived metabolites, and gut microbiota composition-based enterotypes in healthy infants.Methods
Fecal samples were collected from 111 healthy infants randomly administered 1.0 × 109 CFU of B. infantis M-63 or placebo daily from 7 d to 3 months of age. Gut microbial composition characterization using 16S rRNA sequencing and genus-level enterotype clustering was performed. Fecal cytokine, metabolite, short-chain fatty acid, calprotectin, and secretory immunoglobulin A (sIgA) levels were measured.Results
Administering Bifidobacterium infantis M-63 significantly increased gut Bifidobacterium, whereas Enterobacteriaceae abundance and proinflammatory cytokine levels decreased. Six enterotypes were identified among the gut microbiota. In Bifidobacterium-dominant enterotypes, there was a significant increase in acetic acid and tryptophan metabolite levels, and a slight increase in sIgA levels. In contrast, levels of calprotectin and inflammatory cytokines were significantly reduced compared to those in the non-Bifidobacterium enterotypes.Conclusions
Bifidobacterium-dominant enterotypes, established in the gut after administration of B. infantis M-63, were strongly associated with anti-inflammatory effects in healthy infants.Impact
This is the first study to demonstrate an anti-inflammatory effect in healthy full-term infants supplemented with Bifidobacterium infantis M-63 alone. Bifidobacterium-dominant enterotypes were associated with reduced levels of inflammatory cytokines and calprotectin, and increased production of beneficial tryptophan metabolites, such as Indole-3-lactic acid (ILA). This study provides evidence that supplementation with B. infantis M-63 in infants may significantly reduce inflammation during the critical early postnatal period.Research Insights
In Bifidobacterium-dominant enterotypes, there was a significant increase in acetic acid and tryptophan metabolite levels, and a slight increase in sIgA levels.
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 1.0 × 10^9 CFU/day
In Bifidobacterium-dominant enterotypes, there was a significant increase in acetic acid and tryptophan metabolite levels, and a slight increase in sIgA levels.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 1.0 × 10^9 CFU/day
In Bifidobacterium-dominant enterotypes, there was a significant increase in acetic acid and tryptophan metabolite levels, and a slight increase in sIgA levels.
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 1.0 × 10^9 CFU/day
In contrast, levels of calprotectin and inflammatory cytokines were significantly reduced compared to those in the non-Bifidobacterium enterotypes.
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 1.0 × 10^9 CFU/day
Administering Bifidobacterium infantis M-63 significantly increased gut Bifidobacterium, whereas Enterobacteriaceae abundance and proinflammatory cytokine levels decreased.
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 1.0 × 10^9 CFU/day