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

• Published in: Nutrients 2023-03, Vol.15 (6), p.1402
• Main Authors: Hiraku, Akari, Nakata, Setsuko, Murata, Mai, Xu, Chendong, Mutoh, Natsumi, Arai, Satoshi, Odamaki, Toshitaka, Iwabuchi, Noriyuki, Tanaka, Miyuki, Tsuno, Takahisa, Nakamura, Masahiko
• Format: Article
• Language: English
• Subjects: Acetic acid; Antibiotics; Babies; Baby foods; Bifidobacterium; Bifidobacterium longum; Bifidobacterium longum subsp. Infantis; Bifidobacterium longum subspecies infantis; Birth weight; Breast Feeding; Breastfeeding & lactation; Cesarean section; Consent; Defecation; Diabetes; Digestive system; Double-blind studies; Fecal microflora; Feces; Feces - microbiology; Female; Gastrointestinal Microbiome; Gestational age; GI motility; gut microbiota; Hospitals; Humans; Immunoglobulin A; Infant; Infant, Newborn; Infants; Inflammation; Intestinal microflora; Lactose; Metabolism; Microbiota; Milk; Mothers; Multiple births; Nutrition; Placebos; Probiotics; Relative abundance; Sepsis; short-chain fatty acids; term infant
• ISSN: 2072-6643; 2072-6643
• DOI: 10.3390/nu15061402

Bifidobacteria are important intestinal bacteria that provide a variety of health benefits in infants. We investigated the efficacy and safety of subsp. ( ) M-63 in healthy infants in a double-blind, randomized, placebo-controlled trial. Healthy term infants were given M-63 (n = 56; 1 × 10 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 M-63 significantly increased the relative abundance of compared with the placebo group, with a positive correlation with the frequency of breastfeeding. Supplementation with 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 M-63 is well tolerated and contributes to the development of -predominant gut microbiota during a critical developmental phase in term infants.