Non Coeliac Gluten Sensitivity in Children

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Diet, Gluten-Free; Gluten-Sensitive Enteropathy

Treatments: Dietary Supplement: gluten

Study type: Interventional

Funder types: Other

Identifiers

NCT02895438

1408204

2015-A00060-49 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children with Irritable Bowel Syndrome (IBS)

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

gluten

Experimental group

Description:

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.

Treatment:

Dietary Supplement: gluten

Placebo

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: gluten