Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2024-08-28
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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standard of care therapy (control)
Arm does not receive the BHB supplement
No interventions assigned to this group
Standard of care therapy plus BHB supplementation (intervention).
Arm does receives the BHB supplement
Feasibility 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.
Interventions
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Feasibility 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Texas at Austin
OTHER
Responsible Party
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Principal Investigators
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Linda A. Feagins, Associate Professor, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Austin
Locations
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University of Texas at Austin
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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00005294
Identifier Type: -
Identifier Source: org_study_id
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