A randomized, double blind, parallel, placebo‐controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children. Issue 11 (1st September 2021)

• Record Type: Journal Article
• Authors: Wang, Shijie; Xun, Yiping; Ahern, Grace J.; Feng, Lili; Zhang, Dong; Xue, Yuling; Ross, Reynolds Paul; Doolan, Andrea M.; Stanton, Catherine; Zhu, Hong
• Is Part Of: Food science & nutrition. Volume 9:Issue 11(2021)
• Page Start: 6020
• Page End: 6030
• Publication Date: 2021-09-01
• Subjects: caesarean section -- fecal microbiota -- Lactobacillus paracasei N1115 -- probiotic -- short‐chain fatty acid; Food industry and trade -- Periodicals; Food -- Periodicals; Nutrition -- Periodicals; 664
• DOI: 10.1002/fsn3.2533
• Languages: English
• ISSNs: 2048-7177

Abstract

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. Abstract : A randomized, double‐blind, parallel, placebo‐controlled study on Lactobacillus paracasei N1115 (LP N1115) was investigated as a 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. The study results would seem to indicate that efficacy of LP N1115 supplementation at an early age may be effective in enhancing the gut development.