NCT06050811Completed
Prebiotics in Reducing Inflammation and Clinical Endpoints in Ulcerative Colitis (PRInCE-UC)
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
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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 inflammatory bowel disease. It affects 4 in every 1000 people in the UK. UC causes severe episodes of inflammation leading to bloody diarrhoea. The gut microbes of people living with UC are different to those in healthy people. This may be part of the reason people with UC have a more inflamed gut. Prebiotics are types of fibre in the diet which help feed the positive microbes in the colon. Eating them can change the make-up and activity of the bugs which live in our gut in a good way. The goal of this clinical trial is to test the effect of a type of prebiotic called a human milk oligosaccharide (HMO) on the symptoms of patients with UC. The main questions it aims to answer are: * Can a prebiotic improve symptoms for patients living with UC? * Can a prebiotic improve the gut microbiota of people living with UC, and improve markers of inflammation, metabolism and immune function? Patients will take a sachet containing either the prebiotic or a placebo for four weeks, then swap to the other sachet. The trial will be double-blind and randomised. This 'crossover' design means patients act as their own control, which is important in gut microbiology studies. The prebiotic's effect on patient symptoms, metabolism and immune system will be measured. The investigators plan to recruit 44 participants over 18 months. Their urine, blood and stool will be tested. This project will be the first 'bench to bedside' study into the use of prebiotics in IBD. The treatment in this project is rooted in gut model studies. Different prebiotics were tested in the lab to determine which was the best to use for the trial. This 'lab first' approach is a first of its kind.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 8 Sept 2023
- Start date
- 3 Jan 2024
- Primary completion date
- 17 Jun 2025
- Lead sponsor
- Royal Berkshire NHS Foundation Trust
- Diseases
- Ulcerative colitis
- NCT number
- NCT06050811
What you commit to
- Study type: Interventional
- Participants enrolled: 38
- From 3 Jan 2024 to the primary completion date, 17 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
Other
- Patients with acute severe colitis, as defined by the Truelove and Witts criteria
- Introduction of oral 5-ASA within 8 weeks, or dose change of an oral 5-ASA agent within 2 weeks
- Women who are lactating, pregnant or planning pregnancy during the study period.
Who the study is looking for
- 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.)
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Berkshire NHS Foundation Trust Coordinator of this site? Confirm its status | Reading | United Kingdom | Unknown status |
Related publications
- 2'-Fucosyllactose modulates gut microbiota and systemic metabolism in mild-to-moderate ulcerative colitis: a randomized crossover trial.J Crohns Colitis · 2026 · PMID 42635599
This page is information, not medical advice. Discuss any trial with your doctor.