Non Coeliac Gluten Sensitivity in Children

NCT02895438 | Completed

• 2 other identifiers: 14082042015-A00060-49
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Gluten-Free; Gluten-Sensitive Enteropathy

Keywords

Gluten-Sensitive; Diet, Gluten-Free; Irritable Bowel Syndrome; non Coeliac Gluten sensitivity; children

Outcome Measures

Primary Outcomes (1)

• Severity of IBS

  assessed though the composite score of FRANCIS

  12 weeks after randomisation

Secondary Outcomes (2)

• change in gastro-intestinal symptoms

  12 weeks after randomisation

• Change in quality of life

  12 weeks after randomisation

Study Arms (2)

gluten

EXPERIMENTAL

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

Placebo

ACTIVE COMPARATOR

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

Interventions

gluten DIETARY_SUPPLEMENT

Placebo; gluten

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children with Irritable Bowel Syndrome (IBS)

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Celiac Disease; Irritable Bowel Syndrome

Interventions

Glutens

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Colonic Diseases, Functional; Colonic Diseases

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Officials

• Sylvie DESTOMBE, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 9, 2016
• Study Start: May 27, 2015
• Primary Completion: October 4, 2017
• Study Completion: November 22, 2017
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)