Flagyl Microbiome in Crohn's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Crohn Disease
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized 1:1 study groupsMasking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 20 years and 80 years
- Gender
- Both males and females
Description
Participants who are scheduled for colon resection for Crohn's disease will be invited to take part in this randomized study. Participants will be randomized 1:1 to either Metronidazole 250 mg three times a day, starting after surgery, for three months, or the local usual standard of care after surg...
Participants who are scheduled for colon resection for Crohn's disease will be invited to take part in this randomized study. Participants will be randomized 1:1 to either Metronidazole 250 mg three times a day, starting after surgery, for three months, or the local usual standard of care after surgery, which may be a different antibiotic prescribed by the physician. Participants will also provide a stool sample at the following time points: prior to surgery, the day of discharge, at their follow-up appointment (usually about two weeks after surgery), three months, and six months. Participants will also be followed to determine their clinical outcome.
Tracking Information
- NCT #
- NCT04682522
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sandra Kavalukas, MD University of Louisville
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