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

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.

Bifidobacterium longum Subsp. infantis Promotes IgA Level of Growing Mice in a Strain-Specific and Intestinal Niche-Dependent Manner

“…For instance, it has been demonstrated that B. animalis HY8002 raises the IgA level in PP cells [ 21 ], and B. longum subsp. infantis M-63 can also significantly increase fecal IgA levels [ 20 ]. In this study, B. longum subsp.…”

“…Supplementation with B. longum subsp. infantis M-63 significantly upregulated the relative abundance of Bifidobacterium , resulting in elevated fecal IgA levels [ 20 ]. Additionally, B. animalis positively impacted IgA levels in a mouse model and improved intestinal barrier function [ 21 ].…”

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“…The supplementation primarily influenced the genus Bifidobacterium . These findings indicated that administering B. infantis M-63 at a dose of 1 billion per day to healthy full-term infants has a beneficial effect on maintaining infant health by promoting the development of the intestinal microbiota [ 148 ].…”