Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status

Study Overview
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Brief Summary
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Gluten-free diet has been shown to improve gut symptoms in patients with celiac disease and also in adult patients with diagnosis of Irritable Bowel Syndrome (Rome III criteria). Antibodies to native gliadin (AGA) have been suggested as a potential diagnostic marker of response to GFD. However, this has not been tested in a prospective study in IBS patients. Identification of predictors of a symptomatic response to GFD within the IBS population would improve the clinical management of these patients. The purpose of this study is to evaluate the effect of gluten-free diet on gastrointestinal symptoms and gut motility in patients with Irritable Bowel Syndrome stratified according to their antigliadin antibodies status. Additional purposes include investigating effects gluten free diet may have on other parameters: Improvement of mood Quality of life and general well-being Changes in gut microbiota

Official Title
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The Role of Antigliadin Antibodies in Predicting the Beneficial Effect of Gluten Free Diet in Unselected IBS Patients

Conditions
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IBS - Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Gluten free diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients IBS diagnosis (Rome III) Willingness to participate Exclusion Criteria: history of any organic disease including celiac disease Immune deficiency Major abdominal surgery Use of immunosuppressants, glucocorticosteroids or opioids Use of antibiotics in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Intervention GFD in IBS and HV(controls)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gluten free diet<br>Single arm | Other: Gluten free diet<br>* Gluten-free diet- Instructions provided by a dietitian<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement on gastrointestinal symptoms | Decrease >2 points IBS Birmingham score | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of gastrointestinal transit | (SHAPE 25-50 radiopaque markers) | 4 weeks | 
| Improvement anxiety and/or depression | Decrease >2 points Hospital anxiety and depression (HAD) score | 4 weeks | 
| Improvement somatization | Decrease somatization scores (PHQ15) | 4 weeks | 
| Improvement quality of life and well-being | Decrease in the psychological general well-being (PGWB) score | 4 weeks | 
| Changes in gut microbiota | changes in microbial composition | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antigliadin, gluten free diet, transit