Beta-Hydroxybutyrate Feasibility Treating IBD

Official title

Feasibility of Beta-hydroxybutyrate Supplementation to Reduce Inflammation in Patients with Inflammatory Bowel Disease

Overview

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.

Detailed description

A clinical trial designed to determine the feasibility of prebiotic supplementation with beta-hydroxybutyrate (BHB) in Crohn's patients in a prospective, open-label pilot trial and to assess the association between BHB supplementation and changes in the microbiome, inflammation, and markers of disease severity in Crohn's patients in a prospective pre-/post-study design.

Interventions

• Biological 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 measures

• 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]

Secondary outcome measures (8)

• Microbial Diversity [Time frame: 4 weeks]
• BHB Blood Levels [Time frame: 4 weeks]
• Gastrointestinal Symptoms [Time frame: 4 weeks]
• Pain intensity (Patient-Reported Outcomes Measurement Information System (PROMIS) [Time frame: 4 weeks]
• Clinical Response [Time frame: 4 weeks]
• Systemic Inflammation [Time frame: 4 weeks]
• Adverse Events [Time frame: 4 weeks]
• Assess disease activity by Intestinal Ultrasound (IUS) [Time frame: 4 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Texas at Austin — Austin

Identifiers

NCT: NCT06351124 · 00005294

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗