Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-07-09
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Prebiotic at Week 0
Prebiotic
Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.
Prebiotic at Week 8
Prebiotic
Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.
Interventions
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Prebiotic
Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Berkeley Limketkai, MD, PhD
Associate Clinical Professor
Locations
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UCLA
Los Angeles, California, United States
Countries
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Facility Contacts
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Other Identifiers
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24-000256
Identifier Type: -
Identifier Source: org_study_id
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