Non Coeliac Gluten Sensitivity in Children

October 26, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • Chu Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children with Irritable Bowel Syndrome (IBS)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: gluten
Active Comparator: Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of IBS
Time Frame: 12 weeks after randomisation
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
Time Frame: 12 weeks after randomisation
assessed by Visual Analog Scale
12 weeks after randomisation
Change in quality of life
Time Frame: 12 weeks after randomisation
assessed by PedsQL scale
12 weeks after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Sylvie DESTOMBE, MD, Chu Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2015

Primary Completion (Actual)

October 4, 2017

Study Completion (Actual)

November 22, 2017

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1408204
  • 2015-A00060-49 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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