Crohn's Disease, Inflammatory Bowel Diseases
Conditions
Keywords
Beta-hydroxybutyrate (BHB), proinflammatory immune cells, gut bacteria, ketone body, ketogenesis, gut barrier integrity, inflammation, digestive health
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.
Interventions
BIOLOGICALFeasibility 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.
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Eligible consenting patients will be randomized to either standard of care therapy (control) vs standard of care therapy plus BHB supplementation (intervention). BHB will be supplemented as a capsule taken orally three times daily for four weeks for those randomized to the intervention arm.
Intervention model description
This will be a prospective, open-label, randomized, two-arm pilot trial of adults
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to enroll patients who meet the inclusion criteria within the target time frame | 12 months | Number of patients recruited |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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%) |
| Microbial Diversity | 4 weeks | Changes in the microbial diversity and proportional abundance of major bacterial taxa at four weeks compared to baseline |
| 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. |
| Systemic Inflammation | 4 weeks | changes measured by C-reactive protein |
| 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) |
Countries
United States
Contacts
Primary ContactLinda A. Feagins, Associate Professor, MD
Backup ContactJuan P Robayo, Research Program Manager, MPH
Outcome results
None listed