Influence of the Immunosystem in Non-celiac Glutensensitivity

NCT03268720 | Completed

• 1 other identifier: Glutensensitivity
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Gluten Sensitivity

Keywords

gluten sensitivity; gluten-free diet; FODMAP diet; microbiome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Nutrition Analysis for energy intake and nutritional composition by questionnaire Freiburger Nutrition protocol

  2 weeks

• Intraepithelial lymphocytes

  4 weeks

• Goblet cells

  4 weeks

• microbiome

  2 weeks

Study Arms (2)

healthy controls

OTHER

FODMAP low diet gluten-free diet

Other: FODMAP low diet; Other: gluten-free diet

NCGS patients

OTHER

FODMAP low diet gluten-free diet

Other: FODMAP low diet; Other: gluten-free diet

Interventions

FODMAP low diet OTHER

2 week FODMAP low diet

NCGS patients; healthy controls

gluten-free diet OTHER

2 week gluten-free diet

NCGS patients; healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy controls
• patients with glutensensitivity

You may not qualify if:

• patients with glutensensitivity but without celiac disease or wheat allergy

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, 91052, Germany

Location

Related Publications (1)

• Dieterich W, Schuppan D, Schink M, Schwappacher R, Wirtz S, Agaimy A, Neurath MF, Zopf Y. Influence of low FODMAP and gluten-free diets on disease activity and intestinal microbiota in patients with non-celiac gluten sensitivity. Clin Nutr. 2019 Apr;38(2):697-707. doi: 10.1016/j.clnu.2018.03.017. Epub 2018 Apr 4.

  PMID: 29653862 DERIVED

MeSH Terms

Conditions

Celiac Disease

Interventions

FODMAP Diet; Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Participants consume a two week lasting low FODMAP diet, followed by 5 days washout, and subsequent two week gluten-free diet.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 31, 2017
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)