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

Launched by ROYAL BERKSHIRE NHS FOUNDATION TRUST · Sep 17, 2023

Keywords

ClinConnect Summary

The PRInCE-UC clinical trial is studying how a specific type of prebiotic, called human milk oligosaccharides (HMOs), may help improve symptoms in people with ulcerative colitis (UC). UC is a condition that causes inflammation in the intestines, leading to symptoms like bloody diarrhea. Researchers believe that changing the balance of gut microbes might help reduce inflammation and improve health in people with UC. In this trial, participants will take a prebiotic or a placebo (a substance with no active effect) for four weeks, then switch to the other treatment. The study aims to find out if the prebiotic can help relieve symptoms and improve gut health.

To be eligible for this trial, participants need to be adults aged 18 to 64 with a confirmed diagnosis of mildly to moderately active UC. They should not have severe UC or have recently taken certain medications or treatments that could interfere with the study. Throughout the trial, researchers will collect urine, blood, and stool samples to assess the effects of the prebiotic on participants' health. This study is unique because it combines laboratory research with real-life testing, which could lead to new ways of treating UC.

Gender

ALL

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.