Beta-Hydroxybutyrate Feasibility Treating IBD

Phase 1

Recruiting

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

• Registration Number: NCT06351124
• Lead Sponsor: University of Texas at Austin

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.

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 Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-08
• Status Verified: 2024-05
• Study Start: 2024-05-15
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28
• Primary Completion: 2025-04-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care therapy plus BHB supplementation (intervention).	Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's	Arm does receives the BHB supplement

Primary Outcome Measures

Name	Time	Method
Adherence to proposed study timelines and anticipated study costs	12 months	Alignment of predicted timeline and costs to real timeline and costs
Patient adherence to the intervention	12 months	How many dosages do participants miss following the regiment.
Ability to enroll patients who meet the inclusion criteria within the target time frame	12 months	Number of patients recruited

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Texas at Austin; 🇺🇸 Austin, Texas, United States