Non Coeliac Gluten Sensitivity in Children

Not Applicable

Completed

• Conditions: Diet, Gluten-Free; Gluten-Sensitive Enteropathy
• Interventions: Dietary Supplement: gluten

• Registration Number: NCT02895438
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-27
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-09
• Primary Completion: 2017-10-04
• Study Completion: 2017-11-22
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• children with Irritable Bowel Syndrome (IBS)

Exclusion Criteria

• children with Celiac Disease (CD)
• children with wheat allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
gluten	gluten	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.
Placebo	gluten	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.

Primary Outcome Measures

Name	Time	Method
Severity of IBS	12 weeks after randomisation	assessed though the composite score of FRANCIS

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France