Overview

Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)

Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, randomized, controlled open-label add-on design trial pilot study to evaluate the efficacy of personalized adjunctive antibiotic (azithromycin + metronidazole) therapy in pediatric subjects with mild to moderate Crohn's disease (CD) who have a microbiome profile associated with increased risk of early relapse. This an add-on design trial for subjects already receiving standard of care therapy to induce remission; there will be no placebos.
Phase:
Phase 2
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Crohn's and Colitis Foundation
University of Amsterdam
Treatments:
Azithromycin
Metronidazole