Gluten Free Diet in IBS

NCT04247737 | Completed

• 1 other identifier: IBS GFD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gluten Sensitivity

Keywords

non-celiac glutensensitivity; irritable bowel syndrom

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Effect of a gluten free diet on improvement of gastrointestinal symptoms

  six weeks

• Effect of the gluten free diet on Quality of life

  six weeks

• Determination of a subgroup of Patients with NCGS in IBS cohorte

  six weeks

Study Arms (1)

gluten free diet

EXPERIMENTAL

six week gluten free diet

Other: gluten free diet

Interventions

gluten free diet OTHER

Participants keep a gluten free diet for six weeks

gluten free diet

Eligibility Criteria

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

You may qualify if:

• healthy controls without gastrointestinal Symptoms
• patients with irritable bowel Syndrome (Rome IV criteria)

You may not qualify if:

• inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
• celiac disease
• wheat allergy
• pregnancy

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

MeSH Terms

Conditions

Celiac Disease

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 25 healthy individuals and 150 patients with irritable bowel syndrome keep a gluten-free diet for six weeks

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: January 30, 2020
• Study Start: October 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)