Using prebiotics to reduce inflammation in ulcerative colitis

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

This study is testing if a prebiotic called 2'-Fucosyllactose can help people with mild to moderate ulcerative colitis feel better and improve their gut health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Royal Berkshire NHS Foundation Trust (other gov)
• Locations: 1 site (Reading, Berkshire)
• Trial ID: NCT06050811 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a prebiotic called 2'-Fucosyllactose on patients with mild to moderately active ulcerative colitis (UC). Participants will consume the prebiotic for 28 days, followed by a placebo for another 28 days, in a double-blind, cross-over design. The study aims to assess improvements in symptoms, bowel habits, and gut microbiota composition through validated questionnaires and clinical scoring systems. The goal is to determine whether this dietary intervention can enhance the quality of life for individuals suffering from UC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 64 with a diagnosis of mild to moderately active ulcerative colitis.

Not a fit: Patients with acute severe colitis or those who have recently participated in other related trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel dietary approach to alleviate symptoms and improve gut health in patients with ulcerative colitis.

How similar studies have performed: Other studies have shown promising results with prebiotics in gut health, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Reading, Berkshire

• Royal Berkshire NHS Foundation Trust — Reading, Berkshire, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: James M Kennedy, BMBCh

Conditions: Ulcerative Colitis, Gut microbiota, Prebiotic, Human milk oligosaccharide