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NCT06050811: PRInCE-UC
Prebiotics in Reducing Inflammation and Clinical Endpoints in Ulcerative Colitis (PRInCE-UC)
NA trial testing 2'-Fucosyllactose in Ulcerative Colitis in 38 participants. Completed in 17 June 2025.
17 June 2025
Quick facts
| Lead sponsor | Royal Berkshire NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 3 January 2024 |
| Primary completion | 17 June 2025 |
| Estimated completion | 17 June 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- 2'-Fucosyllactose — full drug profile →
- Placebo
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Royal Berkshire NHS Foundation Trust
Who can join
Adults 18 to 64, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Microbiota-targeted strategies in IBD: therapeutic promise of 2'-fucosyllactose and beyond.
Fanous N, Talley NJ, Chaemsupaphan T, Lee E, et al · · 2025 · PMID 41179483 · DOI 10.1177/17562848251386319
Verify or expand the search:
- PubMed search for NCT06050811
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of 2'-Fucosyllactose
Trials testing the same drug.
- NCT06547801 — Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health · NA · completed
- NCT03847467 — Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Thera · Phase 1, PHASE2 · recruiting
Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
- NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
- NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06050811 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Royal Berkshire NHS Foundation Trust
- Last refreshed: 12 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06050811.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing