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Ketone Body Supplement

Beta-Hydroxybutyrate for Crohn's Disease (BHB Trial)

Phase 1 & 2
Recruiting
Led By Linda A. Feagins, Associate Professor, MD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial aims to see if patients with Crohn's disease can take a supplement called beta-hydroxybutyrate (BHB) for 4 weeks while starting new therapy for their disease.

Who is the study for?
This trial is for individuals with Crohn's Disease or Irritable Bowel Syndrome who are starting new treatments. Participants will take a ketone body supplement, beta-hydroxybutyrate (BHB), and must be willing to document their food intake and provide blood and fecal samples at the start and end of the 4-week study.
What is being tested?
The study tests if taking BHB supplements three times daily for four weeks can make it easier for patients to manage Crohn's disease by reducing inflammation and pro-inflammatory bacteria in the gut compared to those not taking the supplement.
What are the potential side effects?
Potential side effects from BHB supplementation may include gastrointestinal discomfort, changes in bowel habits, or an unusual taste in the mouth. However, specific side effects related to this trial have not been detailed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ability to enroll patients who meet the inclusion criteria within the target time frame
Adherence to proposed study timelines and anticipated study costs
Patient adherence to the intervention
Secondary study objectives
Adverse Events
BHB Blood Levels
Clinical Response
+4 more

Trial Design

2Treatment groups
Active Control
Group I: Standard of care therapy plus BHB supplementation (intervention).Active Control1 Intervention
Arm does receives the BHB supplement
Group II: standard of care therapy (control)Active Control1 Intervention
Arm does not receive the BHB supplement

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Who is running the clinical trial?

University of Texas at AustinLead Sponsor
370 Previous Clinical Trials
83,174 Total Patients Enrolled
Linda A. Feagins, Associate Professor, MDPrincipal InvestigatorUniversity of Texas at Austin
~7 spots leftby Apr 2025
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