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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard of care therapy (control) | No Intervention | Arm does not receive the BHB supplement | |
| Standard of care therapy plus BHB supplementation (intervention). | Active Comparator | Arm does receives the BHB supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's | Biological | Is Beta-hydroxybutyrate a supplement that can control symptoms and progression of Crohn's. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to enroll patients who meet the inclusion criteria within the target time frame | Number of patients recruited | 12 months |
| Adherence to proposed study timelines and anticipated study costs | Alignment of predicted timeline and costs to real timeline and costs | 12 months |
| Patient adherence to the intervention | How many dosages do participants miss following the regiment. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial Diversity | Changes in the microbial diversity and proportional abundance of major bacterial taxa at four weeks compared to baseline | 4 weeks |
| BHB Blood Levels | Changes in BHB serum levels at baseline compared to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda A. Feagins, Associate Professor, MD | Contact | 512-495-5641 | linda.feagins@austin.utexas.edu | |
| Juan P Robayo, Research Program Manager, MPH | Contact | 407-928-3556 | juan.robayo@austin.utexas.edu |
| Name | Affiliation | Role |
|---|---|---|
| Linda A. Feagins, Associate Professor, MD | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas at Austin | Recruiting | Austin | Texas | 78712 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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This will be a prospective, open-label, randomized, two-arm pilot trial of adults
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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.
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| 4 weeks |
| Gastrointestinal Symptoms | Changes in (GI PROMIS score) | 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 | 4 weeks |
| Clinical Response | Improved disease activity (reduction in fecal calprotectin by 50%) | 4 weeks |
| Systemic Inflammation | changes measured by C-reactive protein | 4 weeks |
| Adverse Events | Adverse events related to the intervention. Outcomes will be assessed at four weeks follow-up | 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. | 4 weeks |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |