drugset / Trial / NCT06351124

Beta-Hydroxybutyrate Feasibility Treating IBD

NCT06351124 ↗

Phase 1/2 Recruiting 20 enrolled University of Texas at Austin
RandomizedParallel-groupOpen-labelSupportive care

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.

Timeline

Start
2024-08-28
Primary completion
2025-04-01
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator 3-HYDROXYBUTYRIC ACID, (+/-)- Small molecule 3 unknown —

Indications