Non Coeliac Gluten Sensitivity in Children
Primary Purpose
Diet, Gluten-Free, Gluten-Sensitive Enteropathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
gluten
Sponsored by
About this trial
This is an interventional diagnostic trial for Diet, Gluten-Free focused on measuring Gluten-Sensitive, Diet, Gluten-Free, Irritable Bowel Syndrome, non Coeliac Gluten sensitivity, children
Eligibility Criteria
Inclusion Criteria:
- children with Irritable Bowel Syndrome (IBS)
Exclusion Criteria:
- children with Celiac Disease (CD)
- children with wheat allergy
Sites / Locations
- CHU Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
gluten
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
Severity of IBS
assessed though the composite score of FRANCIS
Secondary Outcome Measures
change in gastro-intestinal symptoms
assessed by Visual Analog Scale
Change in quality of life
assessed by PedsQL scale
Full Information
NCT ID
NCT02895438
First Posted
September 6, 2016
Last Updated
October 26, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02895438
Brief Title
Non Coeliac Gluten Sensitivity in Children
Official Title
Does Non Coeliac Gluten Sensitivity (NCGS) Exist in Children? A Double-Blind Randomized Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 27, 2015 (Actual)
Primary Completion Date
October 4, 2017 (Actual)
Study Completion Date
November 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Gluten-Free, Gluten-Sensitive Enteropathy
Keywords
Gluten-Sensitive, Diet, Gluten-Free, Irritable Bowel Syndrome, non Coeliac Gluten sensitivity, children
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gluten
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
gluten
Primary Outcome Measure Information:
Title
Severity of IBS
Description
assessed though the composite score of FRANCIS
Time Frame
12 weeks after randomisation
Secondary Outcome Measure Information:
Title
change in gastro-intestinal symptoms
Description
assessed by Visual Analog Scale
Time Frame
12 weeks after randomisation
Title
Change in quality of life
Description
assessed by PedsQL scale
Time Frame
12 weeks after randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children with Irritable Bowel Syndrome (IBS)
Exclusion Criteria:
children with Celiac Disease (CD)
children with wheat allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie DESTOMBE, MD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non Coeliac Gluten Sensitivity in Children
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