Diet, Gluten-Free, Gluten-Sensitive Enteropathy
Conditions
Keywords
Gluten-Sensitive, Diet, Gluten-Free, Irritable Bowel Syndrome, non Coeliac Gluten sensitivity, children
Brief summary
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* children with Irritable Bowel Syndrome (IBS)
Exclusion criteria
* children with Celiac Disease (CD) * children with wheat allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of IBS | 12 weeks after randomisation | assessed though the composite score of FRANCIS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in gastro-intestinal symptoms | 12 weeks after randomisation | assessed by Visual Analog Scale |
| Change in quality of life | 12 weeks after randomisation | assessed by PedsQL scale |
Countries
France