Gluten Free Diet in IBS

Study Overview
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Brief Summary
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Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. The effect of a gluten-free diet (GFD) on clinical symptom improvement and psychological well-being will be checked in patients with IBS. In addition, the stimulatory potential of gluten on peripheral blood monocytes will be determined. Responders will be provoked with gluten containing bars or placebo bars to confirm the diagnosis of non-celiac glutensenstitivity.

Detailed Description
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Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. Since it has been shown that a gluten free diet (GFD) often alleviates the clinical symptoms, an overlap between patients with IBS and non-celiac glutensensitivity is assumed. The study includes 25 healthy individuals and 150 patients with IBS taking a six week GFD. Participants fill in questionnaires to determine clinical symptoms and psychological well being at the beginning and end of the dietary intervention. Patients with symptom relief under diet are further provoked in a double-blind placebo-controlled study with gluten or placebo containing bars for three weeks, separated by two weeks of washout to diagnosis of NCGS. In addition, peripheral mononuclear cells are isolated at the beginning and end of the diet and the stimulating potential of wheat gluten is analyzed.

Official Title
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Effect of a Gluten Free Diet in Patients With IBS

Conditions
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Gluten Sensitivity

Intervention / Treatment
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* Other: gluten free diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy controls without gastrointestinal Symptoms patients with irritable bowel Syndrome (Rome IV criteria) Exclusion Criteria: inflammatory bowel disease (Crohn's disease, Ulcerative colitis) celiac disease wheat allergy pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: 25 healthy individuals and 150 patients with irritable bowel syndrome keep a gluten-free diet for six weeks
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gluten free diet<br>six week gluten free diet | Other: gluten free diet<br>* Participants keep a gluten free diet for six weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of inflammatory Stimulation of monocytes after gluten exposure | Real-time PCR is used to determine the fold Change of gene expression of Interleukins IL-1ß and IL-6 after 24 hours of stimulation of peripheral monocytes with gluten Fragments (0,5 mg/ml) | six weeks | 
| Differences in Stimulation of inflammatory Parameters between healthy controls and patients with irritable bowel disease (IBD) | Detection of differences in relative gene Expression of inflammatory parameters (IL-1ß and IL-6) between patients with IBD and healthy controls | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of a gluten free diet on improvement of gastrointestinal symptoms | Detection of patients with clinical improvement during gluten free diet, Determination of patients with at least >30% improvement in main gastrointestinal symptoms according the questionnaire for gastrointestinal symptomes (IBS-SSS) | six weeks | 
| Effect of the gluten free diet on Quality of life | Determination of the effect of a gluten free diet on Quality of Life using the Questionnaire psychological index for well being. | six weeks | 
| Determination of a subgroup of Patients with NCGS in IBS cohorte | Detection of patients with IBS that profite from a gluten free diet with Clinical improvement. Determination of the percentage of patients with NCGS compared to whole Population (n=150) | six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-celiac glutensensitivity, irritable bowel syndrom