Beta-Hydroxybutyrate Feasibility Treating IBD

NCT06351124 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 00005294
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn's Disease; Inflammatory Bowel Diseases

Keywords

Beta-hydroxybutyrate (BHB); proinflammatory immune cells; gut bacteria; ketone body; ketogenesis; gut barrier integrity; inflammation; digestive health

Outcome Measures

Primary Outcomes (3)

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

  Number of patients recruited

  12 months

• Adherence to proposed study timelines and anticipated study costs

  Alignment of predicted timeline and costs to real timeline and costs

  12 months

• Patient adherence to the intervention

  How many dosages do participants miss following the regiment.

  12 months

Secondary Outcomes (8)

• Microbial Diversity

  4 weeks

• BHB Blood Levels

  4 weeks

• Gastrointestinal Symptoms

  4 weeks

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

  4 weeks

• Clinical Response

  4 weeks

Study Arms (2)

standard of care therapy (control)

NO INTERVENTION

Arm does not receive the BHB supplement

Standard of care therapy plus BHB supplementation (intervention).

ACTIVE COMPARATOR

Arm does receives the BHB supplement

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

Interventions

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.

Also known as: BHB Feasibility

Standard of care therapy plus BHB supplementation (intervention).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Inflammation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda A. Feagins, Associate Professor, MD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda A. Feagins, Associate Professor, MD

CONTACT

512-495-5641; linda.feagins@austin.utexas.edu

Juan P Robayo, Research Program Manager, MPH

CONTACT

407-928-3556; juan.robayo@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Eligible consenting patients will be randomized to either standard of care therapy (control) vs standard of care therapy plus BHB supplementation (intervention). BHB will be supplemented as a capsule taken orally three times daily for four weeks for those randomized to the intervention arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a prospective, open-label, randomized, two-arm pilot trial of adults

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 8, 2024
• Study Start: August 28, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)