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Non Coeliac Gluten Sensitivity in Children

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ClinicalTrials.gov Identifier: NCT02895438
Recruitment Status : Unknown
Verified September 2016 by Centre Hospitalier Universitaire de Saint Etienne.
Recruitment status was:  Recruiting
First Posted : September 9, 2016
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diet, Gluten-Free Gluten-Sensitive Enteropathy Dietary Supplement: gluten Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Does Non Coeliac Gluten Sensitivity (NCGS) Exist in Children? A Double-Blind Randomized Placebo-Controlled Trial
Study Start Date : April 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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



Primary Outcome Measures :
  1. Severity of IBS [ Time Frame: 12 weeks after randomisation ]
    assessed though the composite score of FRANCIS


Secondary Outcome Measures :
  1. change in gastro-intestinal symptoms [ Time Frame: 12 weeks after randomisation ]
    assessed by Visual Analog Scale

  2. Change in quality of life [ Time Frame: 12 weeks after randomisation ]
    assessed by PedsQL scale



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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with Irritable Bowel Syndrome (IBS)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895438


Contacts
Contact: Sylvie DESTOMBE, MD (0)4 77 82 81 34 ext +33 sylvie.destombe@chu-st-etienne.fr
Contact: Florence Rancon (0)477120284 ext +33 florence.rancon@chu-st-etienne.fr

Locations
France
CHU Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Sylvie DESTOMBE, MD    (0)4 77 82 81 34 ext +33    sylvie.destombe@chu-st-etienne.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Sylvie DESTOMBE, MD CHU Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02895438     History of Changes
Other Study ID Numbers: 1408204
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Gluten-Sensitive
Diet, Gluten-Free
Irritable Bowel Syndrome
non Coeliac Gluten sensitivity
children

Additional relevant MeSH terms:
Hypersensitivity
Intestinal Diseases
Celiac Disease
Immune System Diseases
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Metabolic Diseases