Intestinal Growth of Young Children Clinical Trial
Official title:
A Randomized, Double-blinded, Parallel, Placebo-controlled Study to Investigate the Efficacy of Lb Paracasei [Junlebao Lp. N1115] as a Probiotic to Enhance Gut Development in Young Children
The aim of the study is to examine the intervening effects of N1115 Probiotic Supplement (containing Junlebao Lp. N1115) on gut development in young children at the age of 6 month to 3 years by the way of a randomised, double-blinded, parallel, placebo-controlled clinical trial, and to explore the change of intestinal microbiota composition and healthy condition after intervention.
N1115 Probiotic Supplement contains Lactobacillus paracasei N1115 [Junlebao Lp. N1115], a
lactobacillus bacteria strain isolated from traditional homemade yogurt in North China. In
recent studys feeding Junlebao Lp. N1115 to C57BL/6 mice, the data suggest that Lp. N1115
enhances intestinal development in neonatal mice, and may confer benefits on the growth at
early stage of life.
This study is to investigate if a N1115 Probiotic Supplement product containing Lp. N1115
will improve intestinal health in young children. This randomised, double-blinded,
placebo-controlled trial includes two treatment groups which respectively need to recruit 30
volunteers born by cesarean section and aged from 6 months to 3 years. The study group
receives N1115 Probiotic Supplement, while the control group receives placebo. The trial
lasts for 8 weeks and include four time points of data collection. The stool consistency of
children will be recorded everyday, the saliva and stool samples will be collected and
analysed.
;