Beta-Hydroxybutyrate Feasibility Treating IBD

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT06351124
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's — BIOLOGICAL
    Is Beta-hydroxybutyrate a supplement that can control symptoms and progression of Crohn's.

Study Details

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.

Key Dates

Start date
Aug 28, 2024
Status verified
Sep 2024
Primary completion
Apr 1, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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

Primary Outcome Measure

Ability to enroll patients who meet the inclusion criteria within the target time frame [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas at AustinAustinTexas78712
Michelle Stickler, Associate Vice President, DEd
[email protected]
512-475-6323
Thomas Street, Executive Director
[email protected]
512 495 5142

Find similar trials in Austin, TX

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
University of Texas at Austin· Austin, TX

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