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

Crohn Disease Clinical Trial

Official title: Personalized AZithromycin/metronidAZole, in Combination With Standard Induction Therapy, to Achieve a Fecal Microbiome Community Structure and Metagenome Changes Associated With Sustained Remission in Pediatric Crohn's Disease (CD): a Pilot Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The study hypothesis is that adjunctive antibiotic therapy will improve clinical response to standard of care (SOC) induction therapy in a subgroup of CD patients with a relapse-associated microbiome profile.

Prior to starting SOC induction therapy at week 0, subjects will provide a baseline stool sample that will be screened for microbiome profiles associated with risk of relapse according to an established statistical model.

At week 4, subjects with a relapse-associated microbiome will be randomized into either a control arm that will continue to receive SOC induction therapy for an additional 8 weeks, or a treatment arm that will receive adjunctive antibiotic therapy in addition to continuing to receive SOC induction therapy for an additional 8 weeks. Subjects who do not have a relapse-associated microbiome will enter a separate control arm that will continue to receive SOC induction therapy and will have data collected for exploratory objectives. Subjects who are not in clinical remission by week 4 will receive antibiotic therapy regardless of microbiome signature at baseline. Subjects will be monitored for an additional 40 weeks after the treatment period (52 weeks total). ;

Related Conditions & MeSH terms

• Crohn Disease
• Pediatric Crohns Disease

• NCT number: NCT04186247
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Contact: Johan E Van Limbergen, MD, PhD
• Phone: 31- 20 566 3053
• Email: j.e.vanlimbergen@ansterdamumc.nl
• Status: Recruiting
• Phase: Phase 2
• Start date: August 13, 2021
• Completion date: December 2023