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Search / Trial NCT06249763

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

Biomarkers Treatment Outcome Gluten Diet Microbiome Gastrointestinal Symptoms Fatigue

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.

Locations

Aabenraa, , Denmark

Patients applied

0 patients applied

Trial Officials

Vibeke Andersen, Prof

Principal Investigator

University of Southern Denmark

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported