RECRUITING

Beta-Hydroxybutyrate Feasibility Treating IBD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-28
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06351124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years of age
  2. * Confirmed diagnosis of Crohn's disease
  3. * Active disease defined as either a fecal calprotectin \>250 µg/g or active disease on endoscopy within the prior 3 months
  4. * 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)
  5. * Willing to provide consent for participation.
  6. * Managed at UT Digestive Health Clinic.
  1. * Any current or recent (within 4 weeks) use of BHB supplement
  2. * Currently or recently (within 4 weeks) following a ketogenic diet
  3. * Currently or recently (within 4 weeks) following an intermittent fasting diet
  4. * Any recent antibiotic use (within 3 months)
  5. * Recent infection with C. difficile (within 6 months)
  6. * Current or recent (within 4 weeks) daily use of acid-suppressing therapy (proton pump inhibitor or H2 receptor blocker)
  7. * Current or recent use (within four weeks) of non-dietary probiotic supplements
  8. * Unwilling to provide signed consent

Contacts and Locations

Study Contact

Linda A. Feagins, Associate Professor, MD
CONTACT
512-495-5641
linda.feagins@austin.utexas.edu
Juan P Robayo, Research Program Manager, MPH
CONTACT
407-928-3556
juan.robayo@austin.utexas.edu

Principal Investigator

Linda A. Feagins, Associate Professor, MD
PRINCIPAL_INVESTIGATOR
University of Texas at Austin

Study Locations (Sites)

University of Texas at Austin
Austin, Texas, 78712
United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

  • Linda A. Feagins, Associate Professor, MD, PRINCIPAL_INVESTIGATOR, University of Texas at Austin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-08-28
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Beta-hydroxybutyrate (BHB)
  • proinflammatory immune cells
  • gut bacteria
  • ketone body
  • ketogenesis
  • gut barrier integrity
  • inflammation
  • digestive health

Additional Relevant MeSH Terms

  • Crohn's Disease
  • Inflammatory Bowel Diseases