Diet, Gluten-Free Clinical Trial
Official title:
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.
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