13
Participants
Start Date
August 13, 2021
Primary Completion Date
December 31, 2023
Study Completion Date
December 31, 2023
Azithromycin
Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole
Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care
SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh, Pittsburgh
UCSF Benioff Children's Hospital, San Francisco
IWK Health Centre, Halifax
Wolfson Medical Centre, Tel Aviv
Amsterdam UMC, Amsterdam
Collaborators (1)
Crohn's and Colitis Foundation
OTHER
University of Amsterdam
OTHER
OM Pharma SA
INDUSTRY
University of North Carolina, Chapel Hill
OTHER