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Non Coeliac Gluten Sensitivity in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02895438
Enrollment
20
Registered
2016-09-09
Start date
2015-05-27
Completion date
2017-11-22
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Gluten-Free, Gluten-Sensitive Enteropathy

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTgluten

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* children with Irritable Bowel Syndrome (IBS)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Severity of IBS12 weeks after randomisationassessed though the composite score of FRANCIS

Secondary

MeasureTime frameDescription
change in gastro-intestinal symptoms12 weeks after randomisationassessed by Visual Analog Scale
Change in quality of life12 weeks after randomisationassessed by PedsQL scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026