Flagyl Microbiome in Crohn's Disease
Primary Purpose
Crohn Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metronidazole Oral
Sponsored by
About this trial
This is an interventional basic science trial for Crohn Disease
Eligibility Criteria
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
Sites / Locations
- University Surgical Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Metronidazole
Standard care
Arm Description
Metronidazole 250 mg three times a day
Standard post-operative care, which may or may not include post-operative antibiotics
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04682522
First Posted
December 9, 2020
Last Updated
October 18, 2023
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT04682522
Brief Title
Flagyl Microbiome in Crohn's Disease
Official Title
Does the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2021 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
August 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized 1:1 study groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metronidazole
Arm Type
Active Comparator
Arm Description
Metronidazole 250 mg three times a day
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard post-operative care, which may or may not include post-operative antibiotics
Intervention Type
Drug
Intervention Name(s)
Metronidazole Oral
Other Intervention Name(s)
Flagyl
Intervention Description
250 mg Three times a day
Primary Outcome Measure Information:
Title
Change in bacteria in the gut
Description
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.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Kavalukas, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Surgical Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Flagyl Microbiome in Crohn's Disease
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