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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Wiley
2021
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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) |
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caesarean section fecal microbiota Lactobacillus paracasei N1115 probiotic short‐chain fatty acid Nutrition. Foods and food supply TX341-641 |
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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 |
work_keys_str_mv |
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1718444896425082880 |