A randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children

Abstract In this clinical trial, the safety and effectiveness of Lactobacillus paracasei N1115 (LP N1115) were investigated as a potential probiotic to enhance gut development in young children born by caesarean section. Infants and young children between the ages of 6 months and 3 years were admini...

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Autores principales: Shijie Wang, Yiping Xun, Grace J. Ahern, Lili Feng, Dong Zhang, Yuling Xue, Reynolds Paul Ross, Andrea M. Doolan, Catherine Stanton, Hong Zhu
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Publicado: Wiley 2021
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spelling oai:doaj.org-article:45391579f401486195328ef6c6f619172021-11-04T13:06:43ZA randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children2048-717710.1002/fsn3.2533https://doaj.org/article/45391579f401486195328ef6c6f619172021-11-01T00:00:00Zhttps://doi.org/10.1002/fsn3.2533https://doaj.org/toc/2048-7177Abstract In this clinical trial, the safety and effectiveness of Lactobacillus paracasei N1115 (LP N1115) were investigated as a potential probiotic to enhance gut development in young children born by caesarean section. Infants and young children between the ages of 6 months and 3 years were administered with a probiotic consisting of LP N1115 strain (n = 30) or placebo supplement (n = 30) over an 8 weeks intervention. And the stool consistency, bowel habits, salivary cortisol, fecal microbiota, and short‐chain fatty acid metabolism were investigated. Efficacy data were obtained from 58 participants who completed the study. Overall, the placebo functioned similarly to LP N1115 group in relation to stool consistency, gastrointestinal symptoms, salivary cortisol, and short‐chain fatty acids. However, the scoring data relating to the 6–18 months subgroup receiving LP N1115 remained stable over 8 weeks in comparison to placebo. Analysis of the fecal microbiota using 16S rRNA amplicon sequencing revealed that the phyla Firmicutes represented 62% of the microbial relative abundance in the feces of the subjects during the intervening period. No significant changes in alpha‐ or beta‐diversity were noted between the placebo and LP N1115 groups overtime and at each time point. Differential abundance analysis indicated an increase in Lactobacillus in LP N1115 group at weeks 4 (p < .05) and 8 (p < .05) in comparison to the placebo group. These results suggest that probiotic supplementation with LP N1115 was well tolerated by the young children and subtle changes in the microbiome were noted throughout the intervention period.Shijie WangYiping XunGrace J. AhernLili FengDong ZhangYuling XueReynolds Paul RossAndrea M. DoolanCatherine StantonHong ZhuWileyarticlecaesarean sectionfecal microbiotaLactobacillus paracasei N1115probioticshort‐chain fatty acidNutrition. Foods and food supplyTX341-641ENFood Science & Nutrition, Vol 9, Iss 11, Pp 6020-6030 (2021)
institution DOAJ
collection DOAJ
language EN
topic caesarean section
fecal microbiota
Lactobacillus paracasei N1115
probiotic
short‐chain fatty acid
Nutrition. Foods and food supply
TX341-641
spellingShingle caesarean section
fecal microbiota
Lactobacillus paracasei N1115
probiotic
short‐chain fatty acid
Nutrition. Foods and food supply
TX341-641
Shijie Wang
Yiping Xun
Grace J. Ahern
Lili Feng
Dong Zhang
Yuling Xue
Reynolds Paul Ross
Andrea M. Doolan
Catherine Stanton
Hong Zhu
A randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children
description Abstract In this clinical trial, the safety and effectiveness of Lactobacillus paracasei N1115 (LP N1115) were investigated as a potential probiotic to enhance gut development in young children born by caesarean section. Infants and young children between the ages of 6 months and 3 years were administered with a probiotic consisting of LP N1115 strain (n = 30) or placebo supplement (n = 30) over an 8 weeks intervention. And the stool consistency, bowel habits, salivary cortisol, fecal microbiota, and short‐chain fatty acid metabolism were investigated. Efficacy data were obtained from 58 participants who completed the study. Overall, the placebo functioned similarly to LP N1115 group in relation to stool consistency, gastrointestinal symptoms, salivary cortisol, and short‐chain fatty acids. However, the scoring data relating to the 6–18 months subgroup receiving LP N1115 remained stable over 8 weeks in comparison to placebo. Analysis of the fecal microbiota using 16S rRNA amplicon sequencing revealed that the phyla Firmicutes represented 62% of the microbial relative abundance in the feces of the subjects during the intervening period. No significant changes in alpha‐ or beta‐diversity were noted between the placebo and LP N1115 groups overtime and at each time point. Differential abundance analysis indicated an increase in Lactobacillus in LP N1115 group at weeks 4 (p < .05) and 8 (p < .05) in comparison to the placebo group. These results suggest that probiotic supplementation with LP N1115 was well tolerated by the young children and subtle changes in the microbiome were noted throughout the intervention period.
format article
author Shijie Wang
Yiping Xun
Grace J. Ahern
Lili Feng
Dong Zhang
Yuling Xue
Reynolds Paul Ross
Andrea M. Doolan
Catherine Stanton
Hong Zhu
author_facet Shijie Wang
Yiping Xun
Grace J. Ahern
Lili Feng
Dong Zhang
Yuling Xue
Reynolds Paul Ross
Andrea M. Doolan
Catherine Stanton
Hong Zhu
author_sort Shijie Wang
title A randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children
title_short A randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children
title_full A randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children
title_fullStr A randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children
title_full_unstemmed A randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children
title_sort randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of lactobacillus paracasei n1115 in gut development of young children
publisher Wiley
publishDate 2021
url https://doaj.org/article/45391579f401486195328ef6c6f61917
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