Feasibility of Beta-hydroxybutyrate Supplementation to Reduce Inflammation in Patients with Inflammatory Bowel Disease

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years of age

• Confirmed diagnosis of Crohn's disease

• Active disease defined as either a fecal calprotectin \>250 µg/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.

Locations
United States
Texas
University of Texas at Austin
RECRUITING
Austin
Contact Information
Primary
Linda A. Feagins, Associate Professor, MD
linda.feagins@austin.utexas.edu
512-495-5641
Backup
Juan P Robayo, Research Program Manager, MPH
juan.robayo@austin.utexas.edu
407-928-3556
Time Frame
Start Date: 2024-08-28
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
No_intervention: standard of care therapy (control)
Arm does not receive the BHB supplement
Active_comparator: Standard of care therapy plus BHB supplementation (intervention).
Arm does receives the BHB supplement
Related Therapeutic Areas
Sponsors
Leads: University of Texas at Austin

This content was sourced from clinicaltrials.gov