Actively Recruiting
Beta-Hydroxybutyrate Feasibility Treating IBD
Led by University of Texas at Austin · Updated on 2024-09-19
20
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease. The main questions it aims to answer are: * BHB supplementation will be feasible and acceptable to patients. * BHB supplementation will be associated with a reduction in systemic inflammation. * BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies. Participants will: * Take 3 capsules x 3 times per day for 4 weeks. * Document food consumption using a 24-hour food recall questionnaire. * Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark. Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease.
CONDITIONS
Official Title
Beta-Hydroxybutyrate Feasibility Treating IBD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of Crohn's disease
- Active disease defined as either a fecal calprotectin >250 bcg/g or active disease on endoscopy within the prior 3 months
- Starting a new therapy defined as a biologic (anti-TNF, anti-integrin, IL-12/23, or IL-23) or small molecule therapy (JAK inhibitor, S1P receptor modulator)
- Willing to provide consent for participation
- Managed at UT Digestive Health Clinic
You will not qualify if you...
- Current or recent (within 4 weeks) use of BHB supplement
- Currently or recently (within 4 weeks) following a ketogenic diet
- Currently or recently (within 4 weeks) following an intermittent fasting diet
- Recent antibiotic use (within 3 months)
- Recent infection with C. difficile (within 6 months)
- Current or recent (within 4 weeks) daily use of acid-suppressing therapy (proton pump inhibitor or H2 receptor blocker)
- Current or recent use (within 4 weeks) of non-dietary probiotic supplements
- Unwilling to provide signed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Texas at Austin
Austin, Texas, United States, 78712
Actively Recruiting
Research Team
L
Linda A. Feagins, Associate Professor, MD
CONTACT
J
Juan P Robayo, Research Program Manager, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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