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Beta-Hydroxybutyrate Feasibility Treating IBD

NCT06351124 · University of Texas at Austin
In plain English

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Official title
Feasibility of Beta-hydroxybutyrate Supplementation to Reduce Inflammation in Patients with Inflammatory Bowel Disease
About this study
A clinical trial designed to determine the feasibility of prebiotic supplementation with beta-hydroxybutyrate (BHB) in Crohn's patients in a prospective, open-label pilot trial and to assess the association between BHB supplementation and changes in the microbiome, inflammation, and markers of disease severity in Crohn's patients in a prospective pre-/post-study design.
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Study design
Enrollment target: 20 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-08-28
Estimated completion: 2025-12-31
Last updated: 2024-09-19
Interventions
Biological: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's
Primary outcomes
  • Ability to enroll patients who meet the inclusion criteria within the target time frame (12 months)
  • Adherence to proposed study timelines and anticipated study costs (12 months)
  • Patient adherence to the intervention (12 months)
Sponsor
University of Texas at Austin · other
Contacts & investigators
ContactLinda A. Feagins, Associate Professor, MD · contact · linda.feagins@austin.utexas.edu · 512-495-5641
ContactJuan P Robayo, Research Program Manager, MPH · contact · juan.robayo@austin.utexas.edu · 407-928-3556
InvestigatorLinda A. Feagins, Associate Professor, MD · principal_investigator, University of Texas at Austin
All locations (1)
University of Texas at AustinRecruiting
Austin, Texas, United States
Beta-Hydroxybutyrate Feasibility Treating IBD · TrialPath