Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits (CONSTICHILD)
August 11, 2026 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Shanghai, China
- Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prebiotic fructans
Prebiotic fructans.
Prebiotic will be mixed into foods or drinks and consumed twice daily.
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Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.
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Placebo Comparator: Maltodextrin
Maltodextrin.
Maltodextrin will be mixed into foods or drinks and consumed twice daily.
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Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stool consistency
Time Frame: 4 weeks
|
Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS) comprised of a 4-point scale (A: watery, B: soft, C: formed, D: hard)
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stool frequency
Time Frame: 4 weeks
|
Assessed by daily parental reporting.
|
4 weeks
|
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Stool amount and stool colour
Time Frame: 4 weeks
|
Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS).
Stool amount will be assessed on a 4-point scale (1: smear, 2: up to 25%, 3: 25.50%, 4: >50%, relative to diaper surface).
Stool colour will be assessed on a 6-point scale (I: yellow, II: orange, III: green, IV: brown, V: meconium, VI: clay-coloured)
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4 weeks
|
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Treatment success
Time Frame: 4 weeks
|
ROME IV criteria still met at the end of the intervention.
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4 weeks
|
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Faecal microbiota
Time Frame: 4 weeks
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Stool samples will be analyzed by appropriate molecular biological methods like 16S rRNA gene sequencing to gain insight into the composition of the gut microbiota.
Furthermore, metabolites like SCFA and other organic acids will be measured with appropriate chromatographic methods.
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4 weeks
|
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Faecal Short Chain Fatty Acids concentration
Time Frame: 4 weeks
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Change in Short Chain Fatty Acids over a four week period.
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4 weeks
|
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Faecal pH
Time Frame: 4 weeks
|
Change in faecal pH over a four week period.
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Wei Cai, Doctor, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
- Study Director: Weihui Yan, Doctor, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
- Study Chair: Ying Wang, Doctor, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
- Study Chair: Lina Lu, Doctor, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
- Study Chair: YIjing Tao, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
- Study Chair: Haixia Feng, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
- Study Chair: Yinghong Chen, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
- Study Chair: Anna Li, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 19, 2019
Primary Completion (Actual)
October 26, 2021
Study Completion (Actual)
October 26, 2021
Study Registration Dates
First Submitted
May 6, 2019
First Submitted That Met QC Criteria
May 6, 2019
First Posted (Actual)
May 8, 2019
Study Record Updates
Last Update Posted (Actual)
August 12, 2026
Last Update Submitted That Met QC Criteria
August 11, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-18-016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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