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NCT06351124 · ClinicalTrials.gov registry record · Phase 1
Beta-Hydroxybutyrate Feasibility Treating IBD
A Phase 1 study of Crohn's Disease and Inflammatory Bowel Diseases, sponsored by University of Texas at Austin.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06351124: Recruiting Phase 1 study of Crohn's Disease and Inflammatory Bowel Diseases, sponsored by University of Texas at Austin.
NCT06351124 is a Phase 1 study of Crohn's Disease and Inflammatory Bowel Diseases that is actively recruiting participants, run by University of Texas at Austin. The registered enrollment target is 20 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06351124, a Phase 1 study of Crohn's Disease and Inflammatory Bowel Diseases, is actively recruiting participants, sponsored by University of Texas at Austin.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of patients recruited
Conditions Studied
Interventions
- BIOLOGICAL Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's
Study Locations (1)
Texas
- University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-08-28 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What NCT06351124 shows while recruiting
NCT06351124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's is the first listed.
NCT06351124 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06351124 about?
NCT06351124 is a clinical study titled "Beta-Hydroxybutyrate Feasibility Treating IBD". 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...
What is the current status of trial NCT06351124?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-08-28. Estimated completion is 2025-12-31.
What conditions does trial NCT06351124 study?
This clinical trial studies the following conditions: Crohn's Disease, Inflammatory Bowel Diseases.
What interventions are being tested in trial NCT06351124?
The interventions under investigation include: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's (BIOLOGICAL).
Who is sponsoring clinical trial NCT06351124?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06351124 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06351124's enrollment target sits among peer trials
20 99th of 105 higher than 6 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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