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RecruitingPhase 1Phase 2NCT06351124

Beta-Hydroxybutyrate Feasibility Treating IBD

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

Sponsor

University of Texas at Austin

Enrollment

20 participants

Start Date

Aug 28, 2024

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel DiseasesCrohn's Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether beta-hydroxybutyrate (BHB) — a natural compound produced during fasting or a ketogenic diet, also available as a supplement — can improve the gut microbiome and reduce inflammation in people with active Crohn's disease who are starting a new biologic or small molecule medication. **You may be eligible if...** - You are 18 or older - You have been diagnosed with Crohn's disease - Your disease is currently active (based on lab tests or a recent scope) - You are starting a new biologic therapy (such as anti-TNF, vedolizumab, or ustekinumab) or a small molecule therapy - You are a patient at the UT Digestive Health Clinic **You may NOT be eligible if...** - You are currently taking BHB supplements or following a ketogenic or intermittent fasting diet - You have used antibiotics in the past 3 months - You recently had a C. difficile infection (within 6 months) - You have already been on the biologic or medication you are starting Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFeasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's

Is Beta-hydroxybutyrate a supplement that can control symptoms and progression of Crohn's.

Locations(1)

University of Texas at Austin

Austin, Texas, United States

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NCT06351124

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