Open AccessA randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children
Author(s) -
Wang Shijie,
Xun Yiping,
Ahern Grace J.,
Feng Lili,
Zhang Dong,
Xue Yuling,
Ross Reynolds Paul,
Doolan Andrea M.,
Stanton Catherine,
Zhu Hong
Publication year - 2021
Publication title -
food science and nutrition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.614
H-Index - 27
ISSN - 2048-7177
DOI - 10.1002/fsn3.2533
Subject(s) - lactobacillus paracasei , placebo , feces , probiotic , lactobacillus , medicine , gastroenterology , saliva , biology , physiology , microbiology and biotechnology , food science , bacteria , genetics , alternative medicine , pathology , fermentation
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.