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

Bifidobacteria are important intestinal bacteria that provide a variety of health benefits in infants. We investigated the efficacy and safety of <i>Bifidobacterium longum</i> subsp. <i>infantis</i> (<i>B. infantis</i>) M-63 in healthy infants in a double-blind, r...

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Main Authors: Akari Hiraku, Setsuko Nakata, Mai Murata, Chendong Xu, Natsumi Mutoh, Satoshi Arai, Toshitaka Odamaki, Noriyuki Iwabuchi, Miyuki Tanaka, Takahisa Tsuno, Masahiko Nakamura
Format: Article
Language:English
Published: MDPI AG 2023-03-01
Series:Nutrients
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Online Access:https://www.mdpi.com/2072-6643/15/6/1402
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author Akari Hiraku
Setsuko Nakata
Mai Murata
Chendong Xu
Natsumi Mutoh
Satoshi Arai
Toshitaka Odamaki
Noriyuki Iwabuchi
Miyuki Tanaka
Takahisa Tsuno
Masahiko Nakamura
author_facet Akari Hiraku
Setsuko Nakata
Mai Murata
Chendong Xu
Natsumi Mutoh
Satoshi Arai
Toshitaka Odamaki
Noriyuki Iwabuchi
Miyuki Tanaka
Takahisa Tsuno
Masahiko Nakamura
author_sort Akari Hiraku
collection DOAJ
description Bifidobacteria are important intestinal bacteria that provide a variety of health benefits in infants. We investigated the efficacy and safety of <i>Bifidobacterium longum</i> subsp. <i>infantis</i> (<i>B. infantis</i>) M-63 in healthy infants in a double-blind, randomized, placebo-controlled trial. Healthy term infants were given <i>B. infantis</i> M-63 (n = 56; 1 × 10<sup>9</sup> 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 <i>B. infantis</i> M-63 significantly increased the relative abundance of <i>Bifidobacterium</i> compared with the placebo group, with a positive correlation with the frequency of breastfeeding. Supplementation with <i>B. infantis</i> 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 <i>B. infantis</i> M-63 is well tolerated and contributes to the development of <i>Bifidobacterium</i>-predominant gut microbiota during a critical developmental phase in term infants.
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spelling doaj.art-9104c9c5bde444109372de29896129cd2023-11-17T13:05:16ZengMDPI AGNutrients2072-66432023-03-01156140210.3390/nu15061402Early 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 TrialAkari Hiraku0Setsuko Nakata1Mai Murata2Chendong Xu3Natsumi Mutoh4Satoshi Arai5Toshitaka Odamaki6Noriyuki Iwabuchi7Miyuki Tanaka8Takahisa Tsuno9Masahiko Nakamura10Food Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, JapanDepartment of Pediatrics, Matsumoto City Hospital, 4417-180, Hata, Matsumoto 390-1401, JapanFood Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, JapanFood Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, JapanFood Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, JapanFood Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, JapanNext Generation Science Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, JapanFood Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, JapanFood Ingredients and Technology Institute, R & D Division, Morinaga Milk Industry Co., Ltd., 5-1-83, Higashihara, Zama 252-8583, JapanDepartment of Pediatrics, Matsumoto City Hospital, 4417-180, Hata, Matsumoto 390-1401, JapanDepartment of neurosurgery, Matsumoto City Hospital, 4417-180, Hata, Matsumoto 390-1401, JapanBifidobacteria are important intestinal bacteria that provide a variety of health benefits in infants. We investigated the efficacy and safety of <i>Bifidobacterium longum</i> subsp. <i>infantis</i> (<i>B. infantis</i>) M-63 in healthy infants in a double-blind, randomized, placebo-controlled trial. Healthy term infants were given <i>B. infantis</i> M-63 (n = 56; 1 × 10<sup>9</sup> 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 <i>B. infantis</i> M-63 significantly increased the relative abundance of <i>Bifidobacterium</i> compared with the placebo group, with a positive correlation with the frequency of breastfeeding. Supplementation with <i>B. infantis</i> 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 <i>B. infantis</i> M-63 is well tolerated and contributes to the development of <i>Bifidobacterium</i>-predominant gut microbiota during a critical developmental phase in term infants.https://www.mdpi.com/2072-6643/15/6/1402term infantgut microbiotaprobiotics<i>Bifidobacterium longum</i> subsp. <i>Infantis</i>GI motilityshort-chain fatty acids
spellingShingle Akari Hiraku
Setsuko Nakata
Mai Murata
Chendong Xu
Natsumi Mutoh
Satoshi Arai
Toshitaka Odamaki
Noriyuki Iwabuchi
Miyuki Tanaka
Takahisa Tsuno
Masahiko Nakamura
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
Nutrients
term infant
gut microbiota
probiotics
<i>Bifidobacterium longum</i> subsp. <i>Infantis</i>
GI motility
short-chain fatty acids
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic term infant
gut microbiota
probiotics
<i>Bifidobacterium longum</i> subsp. <i>Infantis</i>
GI motility
short-chain fatty acids
url https://www.mdpi.com/2072-6643/15/6/1402
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