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NCT Number: NCT06351124

Beta-Hydroxybutyrate Feasibility Treating IBD

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammation Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

Is Beta-hydroxybutyrate a supplement that can control symptoms and progression of Crohn's.

Other names: BHB Feasibility

Primary outcomes

  1. Ability to enroll patients who meet the inclusion criteria within the target time frame

    Time frame: 12 months

    Number of patients recruited

  2. Adherence to proposed study timelines and anticipated study costs

    Time frame: 12 months

    Alignment of predicted timeline and costs to real timeline and costs

  3. Patient adherence to the intervention

    Time frame: 12 months

    How many dosages do participants miss following the regiment.

Secondary outcomes

  1. Microbial Diversity

    Time frame: 4 weeks

    Changes in the microbial diversity and proportional abundance of major bacterial taxa at four weeks compared to baseline

  2. BHB Blood Levels

    Time frame: 4 weeks

    Changes in BHB serum levels at baseline compared to 4 weeks

  3. Gastrointestinal Symptoms

    Time frame: 4 weeks

    Changes in (GI PROMIS score)

  4. Pain intensity (Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 4 weeks

    Changes in (PROMIS-29), PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.

    Scales:

    Physical Function 5-1: 5.without any difficulty, 4.with a little difficulty, 3.with some difficulty, 2.with much difficulty, 1.unable Anxiety & Depression 1-5: 1.Never, 2.Rarely, 3.Sometimes, 4.Often, 5.Always Fatigue 5-1: 1.Not at all, 2.A little bit, 3.Somewhat, 2.Quite a bit, 1.Very much Sleep Disturbance 5-1: 5.Very poor, 4.poor 3. fair, 2.Good, 1. very good Ability to participate in social roles and activities 5-1: 5.Never, 4.Rarely, 3.Sometimes, 2.Usually, 1.Always Pain interference 1-5: 1. Not at all, 2.A little bit, 3.Somewhat, 4.Quite a bit, 5.Very much

  5. Clinical Response

    Time frame: 4 weeks

    Improved disease activity (reduction in fecal calprotectin by 50%)

  6. Systemic Inflammation

    Time frame: 4 weeks

    changes measured by C-reactive protein

  7. Adverse Events

    Time frame: 4 weeks

    Adverse events related to the intervention. Outcomes will be assessed at four weeks follow-up

  8. Assess disease activity by Intestinal Ultrasound (IUS)

    Time frame: 4 weeks

    Assess disease activity in patients with inflammatory bowel disease using Intestinal ultrasound (IUS), a noninvasive tool. This can be performed in the clinic at the bedside without any bowel preparation, fasting, or sedation. It is highly acceptable to patients with minimal risk.

Study contacts

Contact information is provided by the study sponsor or research team.

Juan P Robayo, Research Program Manager, MPH

CONTACT

[email protected]

407-928-3556

Linda A. Feagins, Associate Professor, MD

CONTACT

[email protected]

512-495-5641

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

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

Acronym: BHB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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