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Beta-Hydroxybutyrate Feasibility Treating IBD

NCT06351124 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Linda A. Feagins, Associate Professor, MD · University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-28
Primary Completion
2025-04-01
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06351124 on ClinicalTrials.gov