Impact of Prebiotics in Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prebiotic.
- Who it may be relevant to
- Registry conditions: Crohn Disease, Ulcerative Colitis. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis
Overview
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.
Interventions
- Dietary supplement Prebiotic
Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.
Primary outcome measures
- Clinical remission [Time frame: Week 8]
- Change in fecal calprotectin [Time frame: Week 8]
- Microbial composition [Time frame: Week 8]
Secondary outcome measures (5)
- Clinical response [Time frame: Week 8]
- Clinical remission [Time frame: Week 16]
- Clinical response [Time frame: Week 16]
- Change in fecal calprotectin [Time frame: Week 16]
- Microbial composition [Time frame: Week 16]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- UCLA — Los Angeles
Identifiers
NCT: NCT06495658 · 24-000256