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

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    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Updated on 19 July 2021
functional constipation


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


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).

Condition Constipation
Treatment Prebiotic fructans, Non-prebiotic maltodextrin
Clinical Study IdentifierNCT03941925
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Last Modified on19 July 2021


Yes No Not Sure

Inclusion Criteria

Diagnosis of functional constipation following ROME4 criteria
Subject is otherwise healthy at the time of pre-examination
Subject is aged 1-3 years at the time of pre-examination
Subject and caretaker are able and willing to follow the study instructions
Subject is suitable for participation in the study according to the investigator/physician/study personnel
Written informed consent is given by parent or legal guardian

Exclusion Criteria

No legal guardian's command of any local language
Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc
Other metabolic or renal abnormalities or mental retardation (Child's mental delay)
Food allergies or intolerances
Using drugs (e.g. antibiotics) influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention)
Use of laxatives and labelled pre- and probiotics in the previous 2 weeks before the beginning of run-in (4 weeks before intervention)
Subjects who are currently involved or will be involved in another clinical or food study
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