Beta-Hydroxybutyrate Feasibility Treating IBS

Crohn's Disease Clinical Trial

— BHB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06351124
• Other study ID #: 00005294
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 15, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Texas at Austin
• Contact: Linda A. Feagins, Associate Professor, MD
• Phone: 512-495-5641
• Email: linda.feagins[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Irritable Bowel Syndrome

Intervention

Biological:
• Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Inflammatory Bowel Disease
Is Beta-hydroxybutyrate a supplement that can control symptoms and progression of IBS.

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to enroll patients who meet the inclusion criteria within the target time frame	Number of patients recruited	12 months
Primary	Adherence to proposed study timelines and anticipated study costs	Alignment of predicted timeline and costs to real timeline and costs	12 months
Primary	Patient adherence to the intervention	How many dosages do participants miss following the regiment.	12 months
Secondary	Microbial Diversity	Changes in the microbial diversity and proportional abundance of major bacterial taxa at four weeks compared to baseline	4 weeks
Secondary	BHB Blood Levels	Changes in BHB serum levels at baseline compared to 4 weeks	4 weeks
Secondary	Gastrointestinal Symptoms	Changes in (GI PROMIS score)	4 weeks
Secondary	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
Secondary	Clinical Response	Improved disease activity (reduction in fecal calprotectin by 50%)	4 weeks
Secondary	Systemic Inflammation	changes measured by C-reactive protein	4 weeks
Secondary	Adverse Events	Adverse events related to the intervention. Outcomes will be assessed at four weeks follow-up	4 weeks