Early Probiotic Supplementation of Healthy Term Infants with Bifidobacterium longum subsp. infantis M-63 Is Safe and Leads to the Development of Bifidobacterium-Predominant Gut Microbiota: A Double-Blind, Placebo-Controlled Trial

source extracted confidence: high 2026-04-09
#female #humans #infant #infant-newborn #bifidobacterium

Early Probiotic Supplementation of Healthy Term Infants with Bifidobacterium longum subsp. infantis M-63 Is Safe and Leads to the Development of Bifidobacterium-Predominant Gut Microbiota: A Double-Blind, Placebo-Controlled Trial

Hiraku et al., 2023 | Nutrients | Rct

Citation

Hiraku Akari, Nakata Setsuko, ... Nakamura Masahiko. Early Probiotic Supplementation of Healthy Term Infants with Bifidobacterium longum subsp. infantis M-63 Is Safe and Leads to the Development of Bifidobacterium-Predominant Gut Microbiota: A Double-Blind, Placebo-Controlled Trial. Nutrients. 2023-Mar-14;15(6). doi:10.3390/nu15061402

Abstract

Bifidobacteria are important intestinal bacteria that provide a variety of health benefits in infants. We investigated the efficacy and safety of Bifidobacterium longum subsp. infantis (B. infantis) M-63 in healthy infants in a double-blind, randomized, placebo-controlled trial. Healthy term infants were given B. infantis M-63 (n = 56; 1 × 109 CFU/day) or placebo (n = 54) from postnatal age ≤ 7 days to 3 months. Fecal samples were collected, and fecal microbiota, stool pH, short-chain fatty acids, and immune substances were analyzed. Supplementation with B. infantis M-63 significantly increased the relative abundance of Bifidobacterium compared with the placebo group, with a positive correlation with the frequency of breastfeeding. Supplementation with B. infantis M-63 led to decreased stool pH and increased levels of acetic acid and IgA in the stool at 1 month of age compared with the placebo group. There was a decreased frequency of defecation and watery stools in the probiotic group. No adverse events related to test foods were observed. These results indicate that early supplementation with B. infantis M-63 is well tolerated and contributes to the development of Bifidobacterium-predominant gut microbiota during a critical developmental phase in term infants.

Key Findings

infantis M-63 is well tolerated and contributes to the development of Bifidobacterium-predominant gut microbiota during a critical developmental phase in term infants.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population healthy infants
Sample Size 56
Age Range See abstract
Condition See abstract

MeSH Terms

  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Bifidobacterium
  • Gastrointestinal Microbiome
  • Bifidobacterium longum subspecies infantis
  • Breast Feeding
  • Feces
  • Probiotics

Evidence Classification

  • Level: Rct
  • Publication Types: Randomized Controlled Trial, Journal Article
  • Vertical: probiotics-gut

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09