Gluten Free Diet in IBS

Gluten Sensitivity Clinical Trial

Official title:

Effect of a Gluten Free Diet in Patients With IBS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247737
• Other study ID #: IBS GFD
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gluten Sensitivity
• Hypersensitivity

Intervention

Other:
• gluten free diet
Participants keep a gluten free diet for six weeks

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 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
Primary	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	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
Secondary	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
Secondary	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