Flagyl Microbiome in Crohn's Disease

Phase 4

Completed

• Conditions: Crohn Disease
• Interventions: Drug: Metronidazole Oral

• Registration Number: NCT04682522
• Lead Sponsor: University of Louisville

Brief 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.

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-23
• Study Start: 2021-03-21
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• 20-80 years old who is deemed an acceptable surgical candidate for ileocolic resection.

Exclusion Criteria

• any patients that are dependent on total parenteral nutrition and unable to tolerate oral intake
• patients who will undergo resection but will have an ileostomy created
• patients on maintenance antibiotics for their disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronidazole	Metronidazole Oral	Metronidazole 250 mg three times a day

Primary Outcome Measures

Name	Time	Method
Change in bacteria in the gut	six months	Any change in the types of bacteria in the gut during the study period. This will be done by doing genetic analysis of differences in stool over time.

Trial Locations

Locations (1)

University Surgical Associates; 🇺🇸 Louisville, Kentucky, United States