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Search / Trial NCT06351124

Beta-Hydroxybutyrate Feasibility Treating IBD

Launched by UNIVERSITY OF TEXAS AT AUSTIN · Apr 1, 2024

Trial Information

Current as of June 09, 2025

Recruiting

Keywords

Beta Hydroxybutyrate (Bhb) Proinflammatory Immune Cells Gut Bacteria Ketone Body Ketogenesis Gut Barrier Integrity Inflammation Digestive Health

ClinConnect Summary

This clinical trial is looking at whether a supplement called beta-hydroxybutyrate (BHB) can help patients with Crohn's disease. The study will last 4 weeks, and it aims to find out if taking BHB is practical and acceptable for patients, whether it can lower inflammation in the body, and if it can reduce harmful bacteria in the gut. Participants will take three capsules of BHB three times a day, keep track of what they eat, and provide blood and stool samples at the beginning and end of the study.

To join this trial, you need to be at least 18 years old, have a confirmed diagnosis of Crohn's disease that is currently active, and be starting a new treatment for your condition. If you’ve recently used a BHB supplement, followed certain diets, or taken specific medications, you might not be eligible to participate. This study is currently recruiting participants, and it’s a good opportunity for those looking for new ways to manage their Crohn's disease symptoms.

Gender

ALL

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

About University Of Texas At Austin

The University of Texas at Austin, a leading research institution, is dedicated to advancing knowledge and innovation in the field of healthcare through rigorous clinical trials. Known for its commitment to scientific excellence, the university leverages its diverse expertise and cutting-edge facilities to conduct research that addresses critical health challenges. Collaborating with a multidisciplinary team of researchers, clinicians, and students, the University of Texas at Austin aims to translate scientific discoveries into effective treatments and interventions, ultimately enhancing patient outcomes and contributing to the advancement of medical science.

Locations

Austin, Texas, United States

Patients applied

0 patients applied

Trial Officials

Linda A. Feagins, Associate Professor, MD

Principal Investigator

University of Texas at Austin

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported