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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Constipation

Intervention / Treatment
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* Dietary Supplement: Prebiotic fructans
* Dietary Supplement: Non-prebiotic maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prebiotic fructans<br>Prebiotic fructans. Prebiotic will be mixed into foods or drinks and consumed twice daily. | Dietary Supplement: Prebiotic fructans<br>* Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.<br>|
| Placebo Comparator: Maltodextrin<br>Maltodextrin. Maltodextrin will be mixed into foods or drinks and consumed twice daily. | Dietary Supplement: Non-prebiotic maltodextrin<br>* Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prebiotic