Beta-Hydroxybutyrate Feasibility Treating IBD

Phase 2RecruitingNCT06351124

University of Texas at Austin20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Crohn's Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years of age * Confirmed diagnosis of Crohn's disease * Active disease defined as either a fecal calprotectin \&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

Outcomes

Primary Outcomes

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

Number of patients recruited

Time frame: 12 months

Adherence to proposed study timelines and anticipated study costs

Alignment of predicted timeline and costs to real timeline and costs

Time frame: 12 months

Patient adherence to the intervention

How many dosages do participants miss following the regiment.

Time frame: 12 months

Secondary Outcomes

Microbial Diversity

Changes in the microbial diversity and proportional abundance of major bacterial taxa at four weeks compared to baseline

Time frame: 4 weeks

BHB Blood Levels

Changes in BHB serum levels at baseline compared to 4 weeks

Time frame: 4 weeks

Gastrointestinal Symptoms

Changes in (GI PROMIS score)

Time frame: 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

Time frame: 4 weeks

Clinical Response

Improved disease activity (reduction in fecal calprotectin by 50%)

Time frame: 4 weeks

Systemic Inflammation

changes measured by C-reactive protein

Time frame: 4 weeks

Adverse Events

Adverse events related to the intervention. Outcomes will be assessed at four weeks follow-up

Time frame: 4 weeks

Assess disease activity by Intestinal Ultrasound (IUS)

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.

Time frame: 4 weeks

Beta-Hydroxybutyrate Feasibility Treating IBD

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts