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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00060-49 | Other Identifier | ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gluten | Experimental | 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. |
|
| Placebo | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gluten | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of IBS | assessed though the composite score of FRANCIS | 12 weeks after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| change in gastro-intestinal symptoms | assessed by Visual Analog Scale | 12 weeks after randomisation |
| Change in quality of life | assessed by PedsQL scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie DESTOMBE, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D005983 | Glutens |
| ID | Term |
|---|---|
| D055315 | Prolamins |
| D000078522 | Grain Proteins |
| D010940 | Plant Proteins |
| D011506 | Proteins |
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| 12 weeks after randomisation |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D055314 | Seed Storage Proteins |