Non Coeliac Gluten Sensitivity in Children

Study Overview
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Brief Summary
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Irritable Bowel syndrome (IBS) is a very frequent condition in children. Its management is difficult, often resulting in a persistence of chronical abdominal pain. In adults, many patients affected by IBS improve under a gluten-free diet, even in the absence of Celiac Disease (CD) or wheat allergy. This condition is called Non Coeliac Gluten Sensitivity (NCGS). However, it is still not clear how to diagnose and manage NCGS, and the pathophysiological mechanisms also remain elusive. The aim of this study is to determine if NCGS exists in children with IBS and to identify the clinical, serological, and histological characteristics, which could distinguish patients with NCGS from conventional IBS and CD patients. This is a prospective cohort study in a population of children affected by a moderate to severe IBS for more than 6 months. All children had a Gluten Free Diet (GFD) for 6 weeks. Then, children who improved under GFD were randomized in two groups for a double-blind placebo-controled trial. One group had a reintroduction of gluten followed by a wash-out period, then a placebo reintroduction, whereas the other group had the placebo first, then the wash-out and the gluten reintroduction.

Official Title
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Does Non Coeliac Gluten Sensitivity (NCGS) Exist in Children? A Double-Blind Randomized Placebo-Controlled Trial

Conditions
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Diet, Gluten-Free, Gluten-Sensitive Enteropathy

Intervention / Treatment
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* Dietary Supplement: gluten


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with Irritable Bowel Syndrome (IBS) Exclusion Criteria: children with Celiac Disease (CD) children with wheat allergy

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gluten<br>One group had a introduction of gluten followed by a wash-out period, then a placebo introduction, whereas the other group had the placebo first, then the wash-out and the gluten introduction. | Dietary Supplement: gluten<br> <br> |
| Active Comparator: Placebo<br>One group had a introduction of gluten followed by a wash-out period, then a placebo introduction, whereas the other group had the placebo first, then the wash-out and the gluten introduction. | Dietary Supplement: gluten<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of IBS | assessed though the composite score of FRANCIS | 12 weeks after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in gastro-intestinal symptoms | assessed by Visual Analog Scale | 12 weeks after randomisation | 
| Change in quality of life | assessed by PedsQL scale | 12 weeks after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gluten-Sensitive, Diet, Gluten-Free, Irritable Bowel Syndrome, non Coeliac Gluten sensitivity, children