Beta-Hydroxybutyrate Feasibility Treating IBD

Last updated: September 6, 2024
Sponsor: University of Texas at Austin
Overall Status: Active - Recruiting

Phase

1/2

Condition

Colic

Gastrointestinal Diseases And Disorders

Ulcerative Colitis

Treatment

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

Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Inflammatory Bowel Disease

Clinical Study ID

NCT06351124
00005294
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 activedisease on endoscopy within the prior 3 months

  • Starting a new therapy defined as a biologic (anti-TNF, anti-integrin, IL-12/23, orIL-23) or small molecule therapy (JAK inhibitor, S1P receptor modulator)

  • Willing to provide consent for participation.

  • Managed at UT Digestive Health Clinic.

Exclusion

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 (protonpump inhibitor or H2 receptor blocker)

  • Current or recent use (within four weeks) of non-dietary probiotic supplements

  • Unwilling to provide signed consent

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's
Phase: 1/2
Study Start date:
August 28, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University of Texas at Austin

    Austin, Texas 78712
    United States

    Active - Recruiting

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