Flagyl Microbiome in Crohn's Disease

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682522
• Other study ID #: 20.1054
• Status: Completed
• Phase: Phase 4
• Start date: March 21, 2021
• Est. completion date: August 15, 2023

Study information

• Verified date: October 2023
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Metronidazole Oral
250 mg Three times a day

Locations

Country	Name	City	State
United States	University Surgical Associates	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bacteria in the gut	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.	six months