Influence of the Immunosystem in Non-celiac Glutensensitivity

Study Overview
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Brief Summary
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Patients with non-celiac gluten sensitivity (NCGS) complain about gastrointestinal and extraintestinal symptoms while consuming gluten-containing cereals. The symptoms strictly correlate with ingestion of gluten-containing cereals and disappear quickly under elimination diets. Till now, there are no specific markers to diagnose NCGS. This study aims to determine the effect of a low FODMAP diet (fermentable oligo-, di- and monosaccharides and polyols) and a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being. Furthermore, the influence of the diets on the microbiome will be analyzed.

Detailed Description
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Patients with gluten-sensitivity are rigourously checked for wheat allergy and celiac disease. Genotyping for DQ2/8, serological detection of celiac specific antibodies, and gastroduodenoscopy are performed. Furthermore, a skin prick test and detection of wheat specific IgE are done. After exclusion of celiac disease and wheat allergy patients are considered as patients with NCGS. Patients and healthy controls are asked to consume a low FODMAP diet for two weeks, followed by a 5 day washout and subsequent two week gluten-free diet. At the beginning and the end of each diet the participants fill in questionnaires concerning Nutrition (Freiburger Nutrition protocol), psychological well-being index (PGWB), gastrointestinal symptom Rating score (GSRS), and stool consistency (Bristol stool Chart). Furthermore, stool samples are selected at each time point to determine the microbial pattern. NCGS patients with ongoing complaints will have a second gastroduodenoscopy at the end of the study.

Official Title
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Influence of the Immunosystem in Non-celiac Glutensensitivity

Conditions
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Gluten Sensitivity

Intervention / Treatment
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* Other: FODMAP low diet
* Other: gluten-free diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy controls patients with glutensensitivity Exclusion Criteria: patients with glutensensitivity but without celiac disease or wheat allergy

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
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Participants consume a two week lasting low FODMAP diet, followed by 5 days washout, and subsequent two week gluten-free diet.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: healthy controls<br>FODMAP low diet gluten-free diet | Other: FODMAP low diet<br>* 2 week FODMAP low diet<br>Other: gluten-free diet<br>* 2 week gluten-free diet<br>|
| Other: NCGS patients<br>FODMAP low diet gluten-free diet | Other: FODMAP low diet<br>* 2 week FODMAP low diet<br>Other: gluten-free diet<br>* 2 week gluten-free diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of clinical symptomatics | Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score | 2 weeks | 
| Determination of psychological symptoms | Improvement of well-being by questionnaire psychological General well-being index | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition Analysis for energy intake and nutritional composition by questionnaire Freiburger Nutrition protocol | Determination of nutrient intake according to questionnaire Freiburger Nutrition protocol. The questionnaire allows the detailed determination of energy intake, carbohydrates, fatty acids, and Protein. | 2 weeks | 
| Intraepithelial lymphocytes | numbers of intraepithelial lymphocytes in duodenal mucosa | 4 weeks | 
| Goblet cells | numbers of Goblet cells in duodenal mucosa | 4 weeks | 
| microbiome | Analysis of microbiota pattern | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gluten sensitivity, gluten-free diet, FODMAP diet, microbiome