Gluten Free Diet in IBS

Effect of a Gluten Free Diet in Patients With IBS

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.

Study Overview

• Status: Completed
• Conditions: Gluten Sensitivity
• Intervention / Treatment: Other: gluten free diet

Detailed Description

Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. Since it has been shown that a gluten free diet (GFD) often alleviates the clinical symptoms, an overlap between patients with IBS and non-celiac glutensensitivity is assumed. The study includes 25 healthy individuals and 150 patients with IBS taking a six week GFD. Participants fill in questionnaires to determine clinical symptoms and psychological well being at the beginning and end of the dietary intervention. Patients with symptom relief under diet are further provoked in a double-blind placebo-controlled study with gluten or placebo containing bars for three weeks, separated by two weeks of washout to diagnosis of NCGS.

In addition, peripheral mononuclear cells are isolated at the beginning and end of the diet and the stimulating potential of wheat gluten is analyzed.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91052
    • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: gluten free diet; six week gluten free diet	Other: gluten free diet; Participants keep a gluten free diet for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of a gluten free diet on improvement of gastrointestinal symptoms	Detection of patients with clinical improvement during gluten free diet, Determination of patients with at least >30% improvement in main gastrointestinal symptoms according the questionnaire for gastrointestinal symptomes (IBS-SSS)	six weeks
Effect of the gluten free diet on Quality of life	Determination of the effect of a gluten free diet on Quality of Life using the Questionnaire psychological index for well being.	six weeks
Determination of a subgroup of Patients with NCGS in IBS cohorte	Detection of patients with IBS that profite from a gluten free diet with Clinical improvement. Determination of the percentage of patients with NCGS compared to whole Population (n=150)	six weeks

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (ACTUAL): January 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: non-celiac glutensensitivity; irritable bowel syndrom
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: IBS GFD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No