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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.

Keywords: Bifidobacterium longum subsp. Infantis; GI motility; gut microbiota; probiotics; secretory IgA; short-chain fatty acids; term infant.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium infantisIncreased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium infantisIncreased Gut BifidobacteriaBeneficial
Large
Bifidobacterium infantisIncreased Immunoglobulin A LevelsBeneficial
Moderate
Bifidobacterium infantisReduced Faecal pHBeneficial
Moderate
Bifidobacterium infantisSafety of Bifidobacterium infantis SupplementationNeutral
Large
Bifidobacterium infantis BI02Increased Acetic Acid in StoolBeneficial
Moderate
Bifidobacterium infantis BI02Increased Bifidobacterium LevelsBeneficial
Large
Bifidobacterium infantis BI02Increased Stool Immunoglobulin A (IgA)Beneficial
Moderate
Bifidobacterium infantis BI02Reduced Faecal pHBeneficial
Moderate
Bifidobacterium infantis BI02Reduced Frequency of DefecationBeneficial
Small
Bifidobacterium infantis BI02Reduced Watery StoolsBeneficial
Small
Bifidobacterium infantis HA-116Increased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium infantis HA-116Increased Bifidobacterium LevelsBeneficial
Large
Bifidobacterium infantis HA-116Increased Immunoglobulin A LevelsBeneficial
Moderate
Bifidobacterium infantis HA-116Reduced Faecal pHBeneficial
Moderate
Bifidobacterium infantis HA-116Reduced Frequency of DefecationBeneficial
Small
Bifidobacterium infantis HA-116Reduced Watery StoolsBeneficial
Small
Bifidobacterium infantis M-63Increased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium infantis M-63Increased Fecal Secretory IgA LevelsBeneficial
Moderate
Bifidobacterium infantis M-63Increased Gut BifidobacteriaBeneficial
Large
Bifidobacterium infantis M-63Reduced Faecal pHBeneficial
Moderate
Bifidobacterium infantis M-63Reduced Frequency of DefecationBeneficial
Small
Bifidobacterium infantis M-63Reduced Watery StoolsBeneficial
Small
Bifidobacterium infantis MAK22B04IIncreased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium infantis MAK22B04IIncreased Gut BifidobacteriaBeneficial
Large
Bifidobacterium infantis MAK22B04IIncreased Immunoglobulin A LevelsBeneficial
Moderate
Bifidobacterium infantis MAK22B04INo Adverse Food ReactionsNeutral
Large
Bifidobacterium infantis MAK22B04IReduced Faecal pHBeneficial
Moderate
Bifidobacterium infantis MAK22B04IReduced Frequency of DefecationBeneficial
Small
Bifidobacterium infantis MAK22B04IReduced Watery StoolsBeneficial
Small
Bifidobacterium infantis SD-6720Increased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium infantis SD-6720Increased Bifidobacterium LevelsBeneficial
Large
Bifidobacterium infantis SD-6720Increased Fecal Secretory IgA LevelsBeneficial
Moderate
Bifidobacterium infantis SD-6720Reduced Faecal pHBeneficial
Moderate
Bifidobacterium infantis SD-6720Reduced Frequency of DefecationBeneficial
Small
Bifidobacterium infantis SD-6720Reduced Watery StoolsBeneficial
Small
Bifidobacterium infantis VPro 53Absence of Adverse EventsNeutral
Large
Bifidobacterium infantis VPro 53Increased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium infantis VPro 53Increased Bifidobacterium AbundanceBeneficial
Moderate
Bifidobacterium infantis VPro 53Increased Immunoglobulin A LevelsBeneficial
Moderate
Bifidobacterium infantis VPro 53Reduced Faecal pHBeneficial
Moderate
Bifidobacterium longum B1-05Increased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium longum B1-05Increased Fecal Secretory IgA LevelsBeneficial
Moderate
Bifidobacterium longum B1-05Increased Gut BifidobacteriaBeneficial
Large
Bifidobacterium longum B1-05No Adverse Food ReactionsNeutral
Large
Bifidobacterium longum B1-05Reduced Faecal pHBeneficial
Moderate
Bifidobacterium longum B1-05Reduced Frequency of DefecationBeneficial
Small
Bifidobacterium longum B1-05Reduced Watery StoolsBeneficial
Small
Bifidobacterium longum subsp. infantisIncreased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium longum subsp. infantisIncreased Fecal Secretory IgA LevelsBeneficial
Moderate
Bifidobacterium longum subsp. infantisIncreased Gut BifidobacteriaBeneficial
Large
Bifidobacterium longum subsp. infantisNo Adverse Food ReactionsNeutral
Large
Bifidobacterium longum subsp. infantisReduced Faecal pHBeneficial
Moderate
Bifidobacterium longum subsp. infantisReduced Frequency of DefecationBeneficial
Small
Bifidobacterium longum subsp. infantisReduced Watery StoolsBeneficial
Small
Bifidobacterium longum subsp. infantis M-63Increased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium longum subsp. infantis M-63Increased Gut BifidobacteriaBeneficial
Large
Bifidobacterium longum subsp. infantis M-63Increased Stool IgA LevelsBeneficial
Moderate
Bifidobacterium longum subsp. infantis M-63Reduced Faecal pHBeneficial
Moderate
Bifidobacterium longum subsp. infantis M-63Reduced Frequency of DefecationBeneficial
Small
Bifidobacterium longum subsp. infantis M-63Reduced Watery StoolsBeneficial
Small
Bifidobacterium longum subsp. longumIncreased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium longum subsp. longumIncreased Fecal Secretory IgA LevelsBeneficial
Moderate
Bifidobacterium longum subsp. longumIncreased Gut BifidobacteriaBeneficial
Large
Bifidobacterium longum subsp. longumReduced Faecal pHBeneficial
Moderate
Bifidobacterium longum subsp. longumReduced Frequency of DefecationBeneficial
Small
Bifidobacterium longum subsp. longumReduced Watery StoolsBeneficial
Small
Bifidobacterium longum subsp. longum 35624Increased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium longum subsp. longum 35624Increased Fecal Secretory IgA LevelsBeneficial
Moderate
Bifidobacterium longum subsp. longum 35624Increased Gut BifidobacteriaBeneficial
Large
Bifidobacterium longum subsp. longum 35624Reduced Faecal pHBeneficial
Moderate
Bifidobacterium longum subsp. longum 35624Reduced Frequency of DefecationBeneficial
Small
Bifidobacterium longum subsp. longum 35624Reduced Watery StoolsBeneficial
Small
Bifidobacterium longum subsp. longum UABI-14Increased Acetic Acid Levels in FecesBeneficial
Moderate
Bifidobacterium longum subsp. longum UABI-14Increased Bifidobacterium LevelsBeneficial
Large
Bifidobacterium longum subsp. longum UABI-14Increased Serum Immunoglobulin A (IgA) LevelsBeneficial
Moderate
Bifidobacterium longum subsp. longum UABI-14Reduced Faecal pHBeneficial
Moderate
Bifidobacterium longum subsp. longum UABI-14Reduced Frequency of DefecationBeneficial
Small
Bifidobacterium longum subsp. longum UABI-14Reduced Watery StoolsBeneficial
Small
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