Early Probiotic Supplementation of Healthy Term Infants with <i>Bifidobacterium longum</i> subsp. <i>infantis</i> M-63 Is Safe and Leads to the Development of <i>Bifidobacterium</i>-Predominant Gut Microbiota: A Double-Blind, Placebo-Controlled Trial
Akari Hiraku,
Setsuko Nakata,
Mai Murata,
Chendong Xu,
Natsumi Mutoh,
Satoshi Arai,
Toshitaka Odamaki,
Noriyuki Iwabuchi,
Miyuki Tanaka,
Takahisa Tsuno,
Masahiko Nakamura
Affiliations
Akari Hiraku
Food Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, Japan
Setsuko Nakata
Department of Pediatrics, Matsumoto City Hospital, 4417-180, Hata, Matsumoto 390-1401, Japan
Mai Murata
Food Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, Japan
Chendong Xu
Food Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, Japan
Natsumi Mutoh
Food Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, Japan
Satoshi Arai
Food Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, Japan
Toshitaka Odamaki
Next Generation Science Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, Japan
Noriyuki Iwabuchi
Food Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, Japan
Miyuki Tanaka
Food Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, Japan
Takahisa Tsuno
Department of Pediatrics, Matsumoto City Hospital, 4417-180, Hata, Matsumoto 390-1401, Japan
Masahiko Nakamura
Department of neurosurgery, Matsumoto City Hospital, 4417-180, Hata, Matsumoto 390-1401, Japan
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.