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AZithromycin/metronidAZole Therapy for Crohn's Disease (PAZAZ Trial)

Phase 2
Recruiting
Led By Johan E Van Limbergen, MD, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

Summary

This trial is testing whether adding antibiotics to the standard of care for Crohn's disease helps prevent relapse for people whose microbiome profile puts them at increased risk of early relapse.

Eligible Conditions
  • Crohn's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of multinational microbiome-randomized trial
Percent of Subjects with Sustained Remission
Secondary outcome measures
Change in C-Reactive Protein (CRP) Levels in Blood over Baseline to Week 52
Change in Fecal Calprotectin Levels in Stool over Baseline to Week 52
Change in IMPACT-III Score over Baseline to Week 52
+1 more

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of Care + AntibioticsExperimental Treatment3 Interventions
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry. Azithromycin (weeks 4-12) Metronidazole (weeks 4-12)
Group II: Standard of CareExperimental Treatment1 Intervention
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azithromycin
2018
Completed Phase 4
~274950
Metronidazole
2011
Completed Phase 4
~4360

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,526 Previous Clinical Trials
4,197,217 Total Patients Enrolled
Crohn's and Colitis FoundationOTHER
43 Previous Clinical Trials
27,442 Total Patients Enrolled
University of AmsterdamOTHER
42 Previous Clinical Trials
24,263 Total Patients Enrolled

Media Library

Standard of Care Clinical Trial Eligibility Overview. Trial Name: NCT04186247 — Phase 2
Standard of Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04186247 — Phase 2
Crohn's Disease Research Study Groups: Standard of Care, Standard of Care + Antibiotics
Crohn's Disease Clinical Trial 2023: Standard of Care Highlights & Side Effects. Trial Name: NCT04186247 — Phase 2
~5 spots leftby Jul 2025
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