Beta-Hydroxybutyrate Feasibility Treating IBD

Recruiting now · Phase 1/Phase 2

Conditions studied: Crohn's Disease, Inflammatory Bowel Diseases

In brief

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.

Key facts

Study ID

NCT06351124

Run by

University of Texas at Austin

People needed

20

Starts

2024-08-28

Expected to finish

2025-12-31

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Any 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
• Any 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 four weeks) of non-dietary probiotic supplements
• Unwilling to provide signed consent

Where it is running

• University of Texas at Austin — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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