- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06249763
Effects of Gluten Free Diet in Ulcerative Colitis
Effects of Dietary Gluten on Gastrointestinal Symptoms in Ulcerative Colitis: a Randomised Crossover Trial.
The goal is to evaluate gastrointestinal symptoms and fatigue levels during a period of eating gluten free compared to a period of high gluten consumption in individuals with confirmed Ulcerative Colitis, and to identify clinical characteristics in the blood and microbiome of those improving from a gluten free diet. The main questions, the project aims to answer are:
- What is the effect of eating gluten free on patient-reported gastrointestinal symptoms in patients with Ulcerative Colitis?
- What is the effect of eating gluten free on patient-reported fatigue levels in patients with Ulcerative Colitis?
- What are clinical differences between those improving and not improving on fatigue levels and gastrointestinal symptoms?
During two study periods of one week each, participants will be eating gluten free supplemented with daily granola bars without and with high gluten content, respectively. During each active week, participants are asked to:
- Eat gluten free and two daily granola bars delivered by the research team
- Collect blood, stool and urine samples
- Answer questionnaires about their symptoms, disease course, habitual lifestyle, and compliance to the protocol
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction: To meet the growing demand for lifestyle recommendations among patients Ulcerative Colitis (UC) for managing their symptoms and wellbeing, this study aims to evaluate the use of the gluten free diet in the management of UC. Exposure to gluten can activate pro-inflammatory signals in the epithelium that induce mucosal damage, and the protein has previously been associated with disease activity in inflammatory bowel disease, including UC. A suggested pathway for the interaction between disease course and gluten intake is via mucosal damage followed by a flow of pathogens across the intestinal barrier.
To our knowledge, the effect of gluten on UC disease course is not fully understood, and clinical characteristics of patients benefitting from the gluten free diet has not yet been studied. To the patients, fatigue and pain from the gastrointestinal tract are the most burdensome symptoms of UC affecting life quality and restricting everyday activities for the patients. Hence, this study aims to evaluate the effects of dietary gluten in the management of gastrointestinal symptoms and fatigue in UC, and to identify clinical characteristics of patients with UC benefitting from eating gluten free.
Design: In this crossover randomized trial, the outcomes will be assessed after a one-week period of a high-gluten diet and a one-week period of a gluten free diet. Participants and study personnel will be blinded to the dietary intake by granola bars supplementing a complete gluten free diet. The intake of dietary fibres and fructans will be controlled and monitored and controlled for.
Setting: Participants will be recruited from the outpatient clinics for Gastrointestinal Diseases at Hospital Sønderjylland (Hospital of Southern Jutland) in the city of Aabenraa from from January to May 2024. Data collection will be completed in 2024.
Clinical data consist of personal data, patient-reported data on disease activity, gastrointestinal symptoms, fatigue level, health related quality of life and dietary intake, biomarkers in blood, urine and faeces, and protocol compliance measures. Information registered by clinicians and technicians will be transferred from paper format to electronic format using either double entry of data or automated forms processing.
Biologic material consist of blood, faeces and urine samples. All data are treated confidentially and stored according to the Danish Data Protection Regulation and Data Protection Law.
Sample size considerations: Sample size estimation was based on a 1.00 difference in the gastrointestinal symptoms score with a standard deviation (SD) of 1.80 which at a 5% significance level (two-sided) and with 80% statistical power would require a sample size of 28 completing participants. Consequently it was decided to aim for a total sample size of 30 participants, corresponding to a statistical power of 84%.
Project organization: The project is part of a PhD (doctor of philosophy) study. Collaborators are specialists from the gastrointestinal, biochemical and microbiology departments involved in the project and professors in biostatistics and food sciences.
The study is approved by the local Ethics Committee (S-20210174) and the local Data Agency (22/39335). The study findings will be disseminated in peer-reviewed journals, via patient associations, and presented at national and international conferences.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vibeke Andersen, Prof
- Phone Number: 004521157790
- Email: vandersen@health.sdu.dk
Study Contact Backup
- Name: Laura Gregersen, MSc
- Phone Number: 004525548872
- Email: laura.gregersen@rsyd.dk
Study Locations
-
-
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Aabenraa, Denmark, 6200
- Hospital of Southern Jutland
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis: Ulcerative Colitis (UC)
- Language: Can read and understand Danish
- Treatment: No intention to change dose of, begin, or switch medication and biologic treatment within one month after inclusion
- Treatment: Medical and/or biologic treatment type and dose stable for at least 8-16 weeks prior to inclusion depending on the type of treatment
Exclusion Criteria:
- Age: <18 years
- Severe disease activity defined by 6 or more bloody stools per day and/or night and one of the following: fever, pulse ≥ 90, C-reactive protein (CRP) ≥ 30mg/L by the time of inclusion
- Treatment: Have received antibiotic treatment within 4 weeks prior to inclusion
- Treatment: Previous operation for UC
- Concomitant diagnoses: Coeliac Disease (positive Immunoglobolin A against transglutaminase, TGA-IgA) or any cancer diagnosis
- Other: Taking probiotics, are pregnant or breastfeeding, or have nut or wheat allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High gluten
Participants complete both study arms in a crossover design separated by a washout period.
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Trial period B: gluten free diet added daily granola bars with <1 g gluten/day (placebo).
Other Names:
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Placebo Comparator: Gluten free
Participants complete both study arms in a crossover design separated by a washout period.
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Trial period A: gluten free diet added daily granola bars with 10 g gluten/day (intervention).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrointestinal symptoms
Time Frame: 1 week
|
The Gastrointestinal Symptom Rating Scale (GSRS)
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue
Time Frame: 1 week
|
Section I of the Inflammatory Bowel Disease Fatigue patient self-assessment scale (IBD-F) modified to assess the previous week
|
1 week
|
Disease activity
Time Frame: 1 week
|
Simple Clinical Colitis Activity Index (SCCAI)
|
1 week
|
Symptom burden
Time Frame: 1 week
|
Symptom burden measured on the Short Health Scale (SHS)
|
1 week
|
Functional status
Time Frame: 1 week
|
Functional status measured on the Short Health Scale (SHS)
|
1 week
|
Disease-related health burden
Time Frame: 1 week
|
Disease-related health burden measured on the Short Health Scale (SHS)
|
1 week
|
General well-being
Time Frame: 1 week
|
General well-being measured on the Short Health Scale (SHS)
|
1 week
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Joint pain
Time Frame: 1 week
|
100 mm visual analogue scale (VAS)
|
1 week
|
Stool consistency
Time Frame: 1 week
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the Bristol Stool Form Scale (BSFS)
|
1 week
|
Faecal Calprotectin (f-Cal)
Time Frame: 1 week
|
Intestinal inflammatory biomarker
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1 week
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C-reactive protein (CRP)
Time Frame: 1 week
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Acute phase reactant
|
1 week
|
Serum-Zonulin
Time Frame: 1 week
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Exploratory measure of intestinal permeability: Zonulin levels in blood and faeces
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1 week
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Faecal-Zonulin
Time Frame: 1 week
|
Exploratory measure of intestinal permeability: Zonulin levels in blood and faeces
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1 week
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Dietary compliance: diet intake
Time Frame: 1 week
|
Participant reported compliance to the diet (y/n), e.g.
dietary gluten and fructan intake and the number of remaining granola bars by the end of a trial period
|
1 week
|
Urine-Gluten Immunogenic Peptides (GIP)
Time Frame: 1 week
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Supplementing dietary compliance measure: Presence of GIP in urine
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1 week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiome data
Time Frame: 1 week
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Microbiome sequencing of urine and faecal samples
|
1 week
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Potential biomarkers
Time Frame: 1 week
|
Potential biomarkers in biologic material
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1 week
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vibeke Andersen, Prof, University of Southern Denmark
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gluten-UC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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