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Impact of Prebiotics in Ulcerative Colitis
NCT06495658 · University of California, Los Angeles
In plain English
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Official title
The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis
About this study
The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD.
Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.
Eligibility 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
Study design
Enrollment target: 70 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-07-09
Estimated completion: 2027-12-31
Last updated: 2026-02-27
Interventions
Dietary Supplement: Prebiotic
Primary outcomes
- • Clinical remission (Week 8)
- • Change in fecal calprotectin (Week 8)
- • Microbial composition (Week 8)
Sponsor
University of California, Los Angeles · other
All locations (1)
UCLARecruiting
Los Angeles, California, United States