NCT06351124 Beta-Hydroxybutyrate Feasibility Treating IBD
| NCT ID | NCT06351124 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Texas at Austin |
| Condition | Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-08-28 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-08-28 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Linda A. Feagins, Associate Professor, MD
PRINCIPAL INVESTIGATOR
University of Texas at Austin
Frequently Asked Questions
Who can join the NCT06351124 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06351124 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06351124 currently recruiting?
Yes, NCT06351124 is actively recruiting participants. Contact the research team at linda.feagins@austin.utexas.edu for enrollment information.
Where is the NCT06351124 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT06351124 clinical trial?
NCT06351124 is sponsored by University of Texas at Austin. The principal investigator is Linda A. Feagins, Associate Professor, MD at University of Texas at Austin. The trial plans to enroll 20 participants.
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