Clinical Trial

Beta-Hydroxybutyrate Feasibility Treating IBD

Study acronym: BHB
Recruiting Phase 1/2
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Record status
This record was last updated September 19, 2024 (before its estimated April 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-04-01; most recent amendment 2024-09-06.
Status change: Not Yet Recruiting → Recruiting 2024-05-09
Trial Details
NCT Number NCT06351124
Lead Sponsor University of Texas at Austin
Conditions Crohn's Disease, Inflammatory Bowel Diseases
Enrollment 20 participants
Start Date 2024-08-28
Primary Completion 2025-04-01 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-09-19