Influence of the Immunosystem in Non-celiac Glutensensitivity

Not Applicable

Completed

• Conditions: Gluten Sensitivity
• Interventions: Other: FODMAP low diet; Other: gluten-free diet

• Registration Number: NCT03268720
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• healthy controls
• patients with glutensensitivity

Exclusion Criteria

• patients with glutensensitivity but without celiac disease or wheat allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
healthy controls	FODMAP low diet	FODMAP low diet gluten-free diet
healthy controls	gluten-free diet	FODMAP low diet gluten-free diet
NCGS patients	FODMAP low diet	FODMAP low diet gluten-free diet
NCGS patients	gluten-free diet	FODMAP low diet gluten-free diet

Primary Outcome Measures

Name	Time	Method
Determination of clinical symptomatics	2 weeks	Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score
Determination of psychological symptoms	2 weeks	Improvement of well-being by questionnaire psychological General well-being index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg; 🇩🇪 Erlangen, Germany