Effects of Gluten Free Diet in Ulcerative Colitis
Launched by UNIVERSITY OF SOUTHERN DENMARK · Jan 31, 2024
Trial Information
Current as of September 01, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a gluten-free diet on individuals with Ulcerative Colitis, a type of inflammatory bowel disease. Researchers want to understand how eating gluten-free affects symptoms like stomach discomfort and tiredness compared to eating a diet high in gluten. Over two weeks, participants will follow each diet and report their symptoms, while also providing blood, stool, and urine samples to help identify any changes in their condition.
To be eligible for this study, participants must be diagnosed with Ulcerative Colitis, be between the ages of 18 and 74, and be able to read and understand Danish. They should not be planning to change their medication for at least a month before joining the trial. Participants can expect to receive daily granola bars (some gluten-free and some high in gluten) during the study and will fill out questionnaires about their health and lifestyle. This research aims to help understand the potential benefits of a gluten-free diet for those with Ulcerative Colitis.
Gender
ALL
Eligibility criteria
- 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
About University Of Southern Denmark
The University of Southern Denmark (SDU) is a prominent research institution dedicated to advancing knowledge and innovation across various fields, including health sciences. As a clinical trial sponsor, SDU is committed to conducting rigorous and ethically sound research aimed at improving patient outcomes and informing clinical practices. Leveraging its multidisciplinary expertise and state-of-the-art facilities, SDU collaborates with healthcare professionals, industry partners, and regulatory bodies to develop and execute clinical trials that adhere to the highest standards of scientific integrity and compliance. Through its research initiatives, SDU seeks to contribute to the global body of medical knowledge and enhance the quality of healthcare delivery.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aabenraa, , Denmark
Patients applied
Trial Officials
Vibeke Andersen, Prof
Principal Investigator
University of Southern Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported