Effects of Gluten Free Diet in Ulcerative Colitis
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ClinicalTrials.gov Identifier: NCT06249763 |
Recruitment Status :
Not yet recruiting
First Posted : February 8, 2024
Last Update Posted : February 13, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | January 31, 2024 | ||||||||
First Posted Date ICMJE | February 8, 2024 | ||||||||
Last Update Posted Date | February 13, 2024 | ||||||||
Estimated Study Start Date ICMJE | February 2024 | ||||||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Gastrointestinal symptoms [ Time Frame: 1 week ] The Gastrointestinal Symptom Rating Scale (GSRS)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Effects of Gluten Free Diet in Ulcerative Colitis | ||||||||
Official Title ICMJE | Effects of Dietary Gluten on Gastrointestinal Symptoms in Ulcerative Colitis: a Randomised Crossover Trial. | ||||||||
Brief Summary | 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:
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:
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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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Participants are randomised by an external source. Participants, care provider, investigator and outcomes assessor will be blinded to the randomisation. In case of adverse events, the randomization will be revealed to the investigator. Primary Purpose: Supportive Care
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
30 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 2025 | ||||||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Denmark | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT06249763 | ||||||||
Other Study ID Numbers ICMJE | Gluten-UC | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Vibeke Andersen, University of Southern Denmark | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | University of Southern Denmark | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Southern Denmark | ||||||||
Verification Date | February 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |