NCT03941925

Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits

Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Fructans on Bowel Habits of Constipated Young Children One to Three Years of Age

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children.

Detailed description

The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children. It is a double-blind, randomized, placebo-controlled trial.This study plans to recruit into the group of 100 participants (at least 80 of them completed) in 2018-2020.The two groups for the study are product group (prebiotic fructans) and control group (placebo maltodextrin).Duration of intervention is 6 weeks, including 2 weeks for run-in and 4 weeks for intervention.Efficacy parameters are stool consistency (assessed with Amsterdam infant stool scale),stool frequency, stool amount and stool color (assessed with Amsterdam infant stool scale, treatment success, tolerance and acceptability).

Conditions

• Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotic fructans	Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.
DIETARY_SUPPLEMENT	Non-prebiotic maltodextrin	Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-05-08
• Last updated: 2021-07-12

Locations

1 site across 1 country: China