Gluten Free Diet in IBS
Primary Purpose
Gluten Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
gluten free diet
Sponsored by
About this trial
This is an interventional basic science trial for Gluten Sensitivity focused on measuring non-celiac glutensensitivity, irritable bowel syndrom
Eligibility Criteria
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
Sites / Locations
- Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gluten free diet
Arm Description
six week gluten free diet
Outcomes
Primary Outcome Measures
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)
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
Secondary Outcome Measures
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)
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.
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)
Full Information
NCT ID
NCT04247737
First Posted
September 16, 2019
Last Updated
February 18, 2022
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT04247737
Brief Title
Gluten Free Diet in IBS
Official Title
Effect of a Gluten Free Diet in Patients With IBS
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gluten Sensitivity
Keywords
non-celiac glutensensitivity, irritable bowel syndrom
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
25 healthy individuals and 150 patients with irritable bowel syndrome keep a gluten-free diet for six weeks
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gluten free diet
Arm Type
Experimental
Arm Description
six week gluten free diet
Intervention Type
Other
Intervention Name(s)
gluten free diet
Intervention Description
Participants keep a gluten free diet for six weeks
Primary Outcome Measure Information:
Title
Determination of inflammatory Stimulation of monocytes after gluten exposure
Description
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)
Time Frame
six weeks
Title
Differences in Stimulation of inflammatory Parameters between healthy controls and patients with irritable bowel disease (IBD)
Description
Detection of differences in relative gene Expression of inflammatory parameters (IL-1ß and IL-6) between patients with IBD and healthy controls
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Effect of a gluten free diet on improvement of gastrointestinal symptoms
Description
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)
Time Frame
six weeks
Title
Effect of the gluten free diet on Quality of life
Description
Determination of the effect of a gluten free diet on Quality of Life using the Questionnaire psychological index for well being.
Time Frame
six weeks
Title
Determination of a subgroup of Patients with NCGS in IBS cohorte
Description
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)
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Gluten Free Diet in IBS
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