Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits
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- STATUS
- Recruiting
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- End date
- Dec 19, 2022
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- participants needed
- 100
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- sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Summary
The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children.
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).
Details
| Condition | Constipation |
|---|---|
| Treatment | Prebiotic fructans, Non-prebiotic maltodextrin |
| Clinical Study Identifier | NCT03941925 |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
| Last Modified on | 19 July 2021 |
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