Status:
RECRUITING
Impact of Prebiotics in Ulcerative Colitis
Lead Sponsor:
University of California, Los Angeles
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 immunit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06495658
Start Date
July 9 2024
End Date
December 31 2027
Last Update
May 1 2025
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90095