Beta-Hydroxybutyrate Feasibility Treating IBD (BHB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn's Disease
• Intervention / Treatment: Biological: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Linda A. Feagins, Associate Professor, MD; Phone Number: 512-495-5641; Email: linda.feagins@austin.utexas.edu
• Study Contact Backup: Name: Juan P Robayo, Research Program Manager, MPH; Phone Number: 407-928-3556; Email: juan.robayo@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • University of Texas at Austin
      • Contact: Michelle Stickler, Associate Vice President, DEd; Phone Number: 512-475-6323; Email: m.stickler@austin.utexas.edu
      • Contact: Thomas Street, Executive Director; Phone Number: 512 495 5142; Email: thomas.street@austin.utexas.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard of care therapy (control); Arm does not receive the BHB supplement
Active Comparator: Standard of care therapy plus BHB supplementation (intervention).; Arm does receives the BHB supplement	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.; Other Names: BHB Feasibility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial Diversity	Changes in the microbial diversity and proportional abundance of major bacterial taxa at four weeks compared to baseline	4 weeks
BHB Blood Levels	Changes in BHB serum levels at baseline compared to 4 weeks	4 weeks
Gastrointestinal Symptoms	Changes in (GI PROMIS score)	4 weeks
Clinical Response	Improved disease activity (reduction in fecal calprotectin by 50%)	4 weeks
Systemic Inflammation	changes measured by C-reactive protein	4 weeks
Adverse Events	Adverse events related to the intervention. Outcomes will be assessed at four weeks follow-up	4 weeks
Pain intensity (Patient-Reported Outcomes Measurement Information System (PROMIS)	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	4 weeks

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Linda A. Feagins, Associate Professor, MD, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: inflammation; digestive health; gut bacteria; gut barrier integrity; ketogenesis; ketone body; Beta-hydroxybutyrate (BHB); proinflammatory immune cells
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: 00005294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes