A randomized, double blind, parallel, placebo‐controlled st…

Received: 25 January 2021 | Revised: 26 July 2021 | Accepted: 4 August 2021 DOI: 10.1002/fsn3.2533

ORIGINAL RESEARCH

A randomized, double blind, parallel, placebo-controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children | Grace J. Ahern 3,4 | Lili Feng 1 | Dong Zhang 1 | Yuling Xue 1 | Reynolds Paul Ross 3,4 | Andrea M. Doolan 5 | Catherine Stanton 4,6 | Hong Zhu 1 Shijie Wang 1,2 | Yiping Xun 1

1 Shijiazhuang Junlebao Dairy Co. Ltd., Shijiazhuang, China 2 Hebei University of Science & Technology, Shijiazhuang, China 3 School of Microbiology, University College Cork, Cork, Ireland 4 APC Microbiome Institute, University College Cork, Cork, Ireland 5 Atlantia Food Clinical Trials Ltd., Cork, Ireland 6 Teagasc Moorepark Food Research Centre, Fermoy, Ireland Correspondence Hong Zhu, Shijiazhuang Junlebao Dairy Co. Ltd., Shijiazhuang, Hebei 050221, China. Email: zhuhongdr@jlbry.com Funding information This work was supported by the National Key Research and Development Program of China (No. 2016YFD0400605, China), the S&T Program of Hebei (No. 19222812D, No. 19942817G, China), and the Scientific Research and Development Program of Shijiazhuang (No. 201170154A, China)

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 interven - tion. 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 simi - larly 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 compari - son to placebo. Analysis of the fecal microbiota using 16S rRNA amplicon sequenc - ing 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 supplementa - tion with LP N1115 was well tolerated by the young children and subtle changes in the microbiome were noted throughout the intervention period. KEYWORDS caesarean section, fecal microbiota, Lactobacillus paracasei N1115, probiotic, short-chain fatty acid

Shijie Wang, Yiping Xun and Grace J. Ahern should be considered joint first author.

This is an open access article under the terms of the Creat​ive Commo​ns Attri​bution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2021 Shijiazhuang Junlebao Dairy Co. Ltd. Food Science & Nutrition published by Wiley Periodicals LLC.

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Food Sci Nutr. 2021;00:1–11.



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