Beta-Hydroxybutyrate Feasibility Treating IBD (BHB)

The University of Texas System (UT)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Inflammatory Bowel Diseases; Crohn's Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06351124

00005294

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

standard of care therapy (control)

No Intervention group

Description:

Arm does not receive the BHB supplement

Standard of care therapy plus BHB supplementation (intervention).

Active Comparator group

Description:

Arm does receives the BHB supplement

Treatment:

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