Effects of Dietary Gluten on Gastrointestinal Symptoms in Ulcerative Colitis: a Randomised Crossover Trial.
High gluten diet
+ Gluten free diet
Colitis+8
+ Colitis, Ulcerative
+ Colonic Diseases
Supportive Care Study
Summary
Study start date: March 11, 2024
Actual date on which the first participant was enrolled.This study investigates how a gluten-free diet might help people with Ulcerative Colitis (UC) manage their symptoms and improve their overall well-being. UC is a chronic condition that affects the digestive tract, causing symptoms like fatigue and abdominal pain which can severely impact daily life. Some research suggests that gluten, a protein found in wheat and other grains, might worsen inflammation in the gut, leading to more severe symptoms. The goal of this study is to understand whether removing gluten from the diet can alleviate these symptoms and improve the quality of life for UC patients. Participants in the study will undergo two different diet phases: one week on a high-gluten diet and one week on a gluten-free diet, with the order of the diets being randomized. To keep the study unbiased, neither the participants nor the study staff will know which diet is being followed at any given time, thanks to the use of specially controlled granola bars. The study will monitor various factors, including the severity of gastrointestinal symptoms, fatigue levels, and overall health-related quality of life. Biological samples such as blood, urine, and feces will be collected to provide additional data. All information will be kept confidential and managed in line with strict data protection regulations. The study aims to recruit 30 participants to ensure reliable results.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location