Impact of Prebiotics in Ulcerative Colitis
Not applicable · Testing Prebiotic · 1 site · University of California, Los Angeles
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Prebiotic (a dietary supplement). Condition(s) listed: Crohn Disease and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 85
- Any sex
Some of the main requirements, copied from the record:
- Ages 18 to 85 years old
- History of biopsy-proven ulcerative colitis (UC)
- Active symptoms (SCCAI >2)
Plus 3 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- Start date: 2024-07-09.
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Clinical remission (Week 8)
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; Ulcerative Colitis |
| Lead sponsor | University of California, Los Angeles |
| Enrollment | 70 (estimated) |
| Start date | 2024-07-09 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2024-07-11 |
| Last updated | 2026-02-27 |
| Official title | The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT06495658 |
Interventions
- Prebiotic (Dietary Supplement)
Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA | Los Angeles, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.