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

Not Applicable

• Conditions: Constipation
• Interventions: Dietary Supplement: Non-prebiotic maltodextrin; Dietary Supplement: Prebiotic fructans

• Registration Number: NCT03941925
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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).

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Study Start: 2019-07-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-12
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maltodextrin	Non-prebiotic maltodextrin	Maltodextrin. Maltodextrin will be mixed into foods or drinks and consumed twice daily.
Prebiotic fructans	Prebiotic fructans	Prebiotic fructans. Prebiotic will be mixed into foods or drinks and consumed twice daily.

Primary Outcome Measures

Name	Time	Method
Stool consistency	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)

Secondary Outcome Measures

Name	Time	Method
Stool amount and stool colour	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)
Treatment success	4 weeks	ROME IV criteria still met at the end of the intervention.
Faecal microbiota	4 weeks	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.
Stool frequency	4 weeks	Assessed by daily parental reporting.
Faecal Short Chain Fatty Acids concentration	4 weeks	Change in Short Chain Fatty Acids over a four week period.
Faecal pH	4 weeks	Change in faecal pH over a four week period.

Trial Locations

Locations (1)

Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, China