Back to results

Flagyl Microbiome in Crohn's Disease

Primary Purpose

Crohn Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Metronidazole Oral

About this trial

This is an interventional basic science trial for Crohn Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

We'll reach out to this number within 24 hrs