Influence of the Immunosystem in Non-celiac Glutensensitivity

Gluten Sensitivity Clinical Trial

— NCGS  

Official title:

Influence of the Immunosystem in Non-celiac Glutensensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268720
• Other study ID #: Glutensensitivity
• Status: Completed
• Phase: N/A
• First received: August 15, 2017
• Last updated: August 29, 2017
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy controls

• patients with glutensensitivity

Exclusion Criteria:

• patients with glutensensitivity but without celiac disease or wheat allergy

Related Conditions & MeSH terms

• Gluten Sensitivity
• Hypersensitivity

Intervention

Other:
• FODMAP low diet
2 week FODMAP low diet
• gluten-free diet
2 week gluten-free diet

Locations

Country	Name	City	State
Germany	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of clinical symptomatics	Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score	2 weeks
Primary	Determination of psychological symptoms	Improvement of well-being by questionnaire psychological General well-being index	2 weeks
Secondary	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
Secondary	Intraepithelial lymphocytes	numbers of intraepithelial lymphocytes in duodenal mucosa	4 weeks
Secondary	Goblet cells	numbers of Goblet cells in duodenal mucosa	4 weeks
Secondary	microbiome	Analysis of microbiota pattern	2 weeks