Status:
RECRUITING
Prebiotics in Reducing Inflammation and Clinical Endpoints in Ulcerative Colitis (PRInCE-UC)
Lead Sponsor:
Royal Berkshire NHS Foundation Trust
Collaborating Sponsors:
University of Reading
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
The community of microbes living in the gut is called the 'gut microbiome'. Changing this could be an exciting new way of treating people living with ulcerative colitis (UC). UC is a type of inflamma...
Detailed Description
This dietary intervention study will be carried out in a double-blind, cross-over manner, whereby 44 participants with mild to moderately active UC will be asked to consume an appropriate dose of the ...
Eligibility Criteria
Inclusion
- Signed consent form
- Adults (aged from 18 to 64)
- Diagnosis of ulcerative colitis by endoscopy and histology
- Mildly or moderately active UC (based on symptom score and gastroenterologist opinion, with elevated serum C-reactive protein above reference range for local laboratory and/or faecal calprotectin of 150 μg/g or greater and/or endoscopic disease activity, the latter three criteria having been within the past 2 months.)
Exclusion
- Patients with acute severe colitis, as defined by the Truelove and Witts criteria
- Intake of an experimental drug within four weeks prior to study
- Former participation in prebiotic or laxative trials within the previous three months
- Use of antibiotics within the previous four weeks
- Introduction of an immunomodulator or advanced therapy (e.g. biologic) within 12 weeks or dose change of an immunomodulator or advanced therapy within 6 weeks
- Introduction of oral 5-ASA within 8 weeks, or dose change of an oral 5-ASA agent within 2 weeks
- Use of corticosteroids within preceding 6 weeks or during trial period
- Intake of other specific prebiotics (such as oligosaccharides e.g. inulin), or probiotics (e.g. live yoghurts, other fermented products), drugs active on gastrointestinal motility, or a laxative of any class, for four weeks prior to study.
- Women who are lactating, pregnant or planning pregnancy during the study period.
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06050811
Start Date
January 3 2024
End Date
November 1 2024
Last Update
May 9 2024
Active Locations (1)
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1
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, United Kingdom, RG1 5AN