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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02895438
Other study ID # 1408204
Secondary ID 2015-A00060-49
Status Completed
Phase N/A
First received
Last updated
Start date May 27, 2015
Est. completion date November 22, 2017

Study information

Verified date October 2018
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 22, 2017
Est. primary completion date October 4, 2017
Accepts healthy volunteers No
Gender All
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria:

- children with Irritable Bowel Syndrome (IBS)

Exclusion Criteria:

- children with Celiac Disease (CD)

- children with wheat allergy

Study Design


Intervention

Dietary Supplement:
gluten


Locations

Country Name City State
France CHU Saint-Etienne Saint-Etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of IBS assessed though the composite score of FRANCIS 12 weeks after randomisation
Secondary change in gastro-intestinal symptoms assessed by Visual Analog Scale 12 weeks after randomisation
Secondary Change in quality of life assessed by PedsQL scale 12 weeks after randomisation
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