Clinical trial NCT06351124: Beta-Hydroxybutyrate Feasibility Treating IBD
Official title: Feasibility of Beta-hydroxybutyrate Supplementation to Reduce Inflammation in Patients with Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
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
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a prospective, open-label, randomized, two-arm pilot trial of adults
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years of age
* Confirmed diagnosis of Crohn's disease
* Active disease defined as either a fecal calprotectin \&amp;amp;gt;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

Primary outcomes:
measure: Ability to enroll patients who meet the inclusion criteria within the target time frame
timeFrame: 12 months
measure: Adherence to proposed study timelines and anticipated study costs
timeFrame: 12 months
measure: Patient adherence to the intervention
timeFrame: 12 months
Secondary outcomes:
measure: Microbial Diversity
timeFrame: 4 weeks
measure: BHB Blood Levels
timeFrame: 4 weeks
measure: Gastrointestinal Symptoms
timeFrame: 4 weeks
measure: Pain intensity (Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 4 weeks
measure: Clinical Response
timeFrame: 4 weeks
measure: Systemic Inflammation
timeFrame: 4 weeks
measure: Adverse Events
timeFrame: 4 weeks
measure: Assess disease activity by Intestinal Ultrasound (IUS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Linda A. Feagins, Associate Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: