NCT03416595

A Study on Efficacy of Feeding N1115 Probiotic Supplement to Young Children

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Junlebao Dairy Group Co., Ltd. · Industry
• Sex: All
• Age: 6 Months – 3 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Intestinal Growth of Young Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	N1115 Probiotic Supplement	Participators will receive a sachet each day during 8 weeks. The contents of the sachet should be added to warm water or milk, mixed until fully dissolved and served within 15 minutes.
DIETARY_SUPPLEMENT	placebo	Participators will receive a sachet each day during 8 weeks. The contents of the sachet should be added to warm water or milk, mixed until fully dissolved and served within 15 minutes.

Timeline

• Start date: 2017-09-18
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2018-01-31
• Last updated: 2018-07-24

Locations

1 site across 1 country: Ireland