NCT04682522

Flagyl Microbiome in Crohn's Disease

Does the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the types of bacteria in the colon before and after colon resection surgery. The investigator will also compare standard post-operative antibiotic treatment to flagyl (metronidazole) treatment post-operatively to see if giving the antibiotic, decreases the incidence of return of Crohn's disease.

Detailed 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 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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Metronidazole Oral	250 mg Three times a day

Timeline

• Start date: 2021-03-21
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2020-12-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study