Influence of dietary prebiotics in ulcerative colitis
Research type
Research Study
Full title
A randomised, placebo-controlled, double-blinded crossover trial investigating the effect of a dietary prebiotic on clinical, metabonomic, microbiological, and immunological outcomes in patients with mild to moderate ulcerative colitis
IRAS ID
325815
Contact name
Glenn Gibson
Contact email
Sponsor organisation
University of Reading
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
This study will look at whether prebiotics can improve symptoms for people living with Ulcerative Colitis (UC). This project will have two sections: First, a 'batch culture' gut model will be used to study the effect of various prebiotics on the microbes in stool from patients with UC. A prebiotic which works best in a gut model in the lab will then be taken forward to a clinical trial in people with active UC. This trial will look at the effect of the prebiotic compared to a placebo on bowel symptoms and key changes in participants' metabolism and immune system. The cross-over design of the trial means patients are their own control subjects. Patients will take either the prebiotic or a placebo for 28 days, then have a 21 day period with no product, then
swap to the other treatment for another 28 days. We plan to recruit 40 participants over 12-18 months. During the study they will keep diaries of their symptoms, and provide blood, urine and stool samples at weeks 0, 4, 7, 10 and 14. This project is novel for a few reasons. It will be the first ‘bench-to-bedside’ study into the use of prebiotics in IBD. We will also be carrying out a 'functional assessment' to look at how the microbes interact with the human host and a food based therapy for UC would not suppress the immune system, unlike many drugs we currently use.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0080
Date of REC Opinion
23 Mar 2023
REC opinion
Further Information Favourable Opinion