Prebiotics in Reducing Inflammation and Clinical Endpoints in Ulcerative Colitis (PRInCE-UC)

NCT06050811 | Completed

• 1 other identifier: PRInCE-UC
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ulcerative Colitis

Keywords

Gut microbiota; Prebiotic; Human milk oligosaccharide

Outcome Measures

Primary Outcomes (1)

• Clinical response measured using Simple Clinical Colitis Activity Index

  Clinically significant improvement in patient symptoms as defined by a decrease in Simple Clinical Colitis Activity Index Score of greater than or equal to 2 points from baseline.

  Four weeks

Secondary Outcomes (9)

• Clinical remission measured using Simple Clinical Colitis Activity Index

  Four weeks

• Colonic inflammation

  Four weeks

• Changes in faecal microbiota composition

  Four weeks

• Faecal bacterial metabolites

  Four weeks

• Changes in urinary metabolites

  Four weeks

Study Arms (2)

Prebiotic supplement

EXPERIMENTAL

5 g 2'-Fucosyllactose per day

Dietary Supplement: 2'-Fucosyllactose

Placebo

PLACEBO COMPARATOR

5 g maltodextrin per day

Dietary Supplement: Placebo

Interventions

2'-Fucosyllactose DIETARY_SUPPLEMENT

2'-Fucosyllactose given orally with water or food for four weeks, followed by a three week washout period.

Prebiotic supplement

Placebo DIETARY_SUPPLEMENT

Maltodextrin given orally with water or food for four weeks, followed by a three week washout period.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Reading: collaborator
• Royal Berkshire NHS Foundation Trust: lead

Study Sites (1)

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, RG1 5AN, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

2'-fucosyllactose

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Glenn Gibson, PhD

  University of Reading

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The candidate prebiotic and placebo will be pre-packaged randomly off-site, and the investigator and patient will not know whether the prebiotic or the placebo is being administered. This will be unmasked for the data analysis phase.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Volunteers will be assigned randomly to take either prebiotic or placebo during an initial 28 day period. A 21 day wash-out period, during which no prebiotic or placebo will be consumed, will separate the 28 day treatment periods and there will be a further washout at the end (to ascertain the duration of prebiotic effect). There will therefore be four test periods randomly assigned (prebiotic; washout; placebo; washout; OR placebo; washout; prebiotic; washout).

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 22, 2023
• Study Start: January 3, 2024
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)