Recruiting
Phase 1
Phase 2

Beta-Hydroxybutyrate

Sponsor:

University of Texas at Austin

Code:

NCT06351124

Conditions

Crohn's Disease

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's

Study Details

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.

Conditions

Crohn's Disease

Inflammatory Bowel Diseases

Study ID

NCT06351124

Start date

Aug 28, 2024

Status verified date

Sep, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Apr 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: standard of care therapy (control)

Arm does not receive the BHB supplement

active comparator: Standard of care therapy plus BHB supplementation (intervention).

Arm does receives the BHB supplement

Interventions

Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's

Is Beta-hydroxybutyrate a supplement that can control symptoms and progression of Crohn's.

Primary outcome measure

  • Ability to enroll patients who meet the inclusion criteria within the target time frame [ Time Frame: 12 months ]
  • Adherence to proposed study timelines and anticipated study costs [ Time Frame: 12 months ]
  • Patient adherence to the intervention [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Linda A. Feagins, Associate Professor, MD

512-495-5641linda.feagins@austin.utexas.edu

Juan P Robayo, Research Program Manager, MPH

407-928-3556juan.robayo@austin.utexas.edu

Locations

University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Michelle Stickler, Associate Vice President, DEd

512-475-6323m.stickler@austin.utexas.edu

Thomas Street, Executive Director

512 495 5142thomas.street@austin.utexas.edu

More Information

Sponsor

University of Texas at Austin

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2024-09-19.