Using beta-hydroxybutyrate to treat Crohn's disease
Feasibility of Beta-hydroxybutyrate Supplementation to Reduce Inflammation in Patients with Inflammatory Bowel Disease
This study is testing if taking beta-hydroxybutyrate supplements can help people with Crohn's disease feel better by reducing inflammation and improving their gut health.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas at Austin Academic / other |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT06351124 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the feasibility of beta-hydroxybutyrate (BHB) supplementation in patients with Crohn's disease over a 4-week period. Participants will take BHB capsules three times a day while documenting their food intake and providing blood and fecal samples at the start and end of the study. The trial aims to assess whether BHB can reduce systemic inflammation and pro-inflammatory bacterial colonies, comparing outcomes between those taking the supplement and those not. The study is designed as a prospective, open-label pilot trial to gather preliminary data on the effects of BHB on the microbiome and disease severity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of active Crohn's disease who are starting a new therapy.
Not a fit: Patients who have recently used BHB supplements or followed a ketogenic diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary supplement option to help manage inflammation in Crohn's disease patients.
How similar studies have performed: While the use of BHB in this context is novel, other studies have explored dietary interventions for inflammatory bowel diseases with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Austin, Texas
- University of Texas at Austin — Austin, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Linda A. Feagins, Associate Professor, MD — University of Texas at Austin
- Study coordinator: Linda A. Feagins, Associate Professor, MD
- Email: linda.feagins@austin.utexas.edu
- Phone: 512-495-5641
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.