Beta-Hydroxybutyrate for Crohn's Disease

This study is looking at whether a supplement called beta-hydroxybutyrate (BHB) can help people with Crohn's disease who are starting a new treatment. Researchers want to see if taking BHB capsules for 4 weeks is practical and acceptable for patients. They also want to find out if BHB might reduce inflammation and change the types of bacteria in the gut. You could join if you are at least 18 years old, have a confirmed diagnosis of Crohn's disease with active symptoms (like a fecal calprotectin level above 250 µg/g or active disease seen on endoscopy), and are starting a new therapy for your Crohn's. This study aims to enroll 20 participants.

Study design
This is an open-label pilot study, meaning you and the researchers will know you are receiving the beta-hydroxybutyrate supplement. It is designed to see if the treatment is feasible for patients with Crohn's disease.
What's involved
You would take 3 capsules of beta-hydroxybutyrate, three times a day, for 4 weeks. You would also complete a 24-hour food recall questionnaire and provide blood and stool samples twice: at the beginning and after 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will track certain aspects, like your adherence to the intervention, for 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06351124

Beta-Hydroxybutyrate Feasibility Treating IBD

Recruiting
PHASE1Ages 18+InterventionalSupportive care
University of Texas at Austin
~20 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ability to enroll patients who meet the inclusion criteria within the target time frame
Measured over 12 months
+2 more outcomes measured
Crohn's Disease
Inflammatory Bowel Diseases
1 sites across 1 states
Texas1
  • Linda A. Feagins, Associate Professor, MD · PRINCIPAL_INVESTIGATOR · University of Texas at Austin
Linda A. Feagins, Associate Professor, MD
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Eligibility criteria

Inclusion

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

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
  • Ability to enroll patients who meet the inclusion criteria within the target time frame12 months

    Number of patients recruited

  • Adherence to proposed study timelines and anticipated study costs12 months

    Alignment of predicted timeline and costs to real timeline and costs

  • Patient adherence to the intervention12 months

    How many dosages do participants miss following the regiment.