Effects of prebiotics on gut health in ulcerative colitis
The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis
This study is testing if taking prebiotics can improve gut health in people with ulcerative colitis who have active symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06495658 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of prebiotic supplementation on gut microbiome composition and overall gut health in patients with ulcerative colitis. Participants aged 18 to 85 with active symptoms will be randomized to receive prebiotics for either 8 weeks starting at week 0 or week 8. Dietary composition will be assessed at baseline and throughout the 16-week period, with stool samples collected for analysis of microbial changes. The goal is to understand how dietary interventions can influence IBD outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 85 with a history of biopsy-proven ulcerative colitis and active symptoms.
Not a fit: Patients who have undergone prior colectomy or have unstable major medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new dietary strategies to improve gut health and manage symptoms in patients with ulcerative colitis.
How similar studies have performed: Previous studies have indicated that dietary interventions can positively affect gut microbiome composition, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 18 to 85 years old * History of biopsy-proven ulcerative colitis (UC) * Active symptoms (SCCAI \>2) * Concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment. * Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment. * Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial Exclusion Criteria: * Prior colectomy * Hospitalization * Urgent need for abdominal surgery * Unstable major medical condition * Active malignancy under treatment * Active alcohol or non-cannabinoid substance abuse * Pregnancy or lactation * Concerns for non-compliance
Where this trial is running
Los Angeles, California
- UCLA — Los Angeles, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.