Flagyl Microbiome in Crohn's Disease

NCT ID: NCT04682522

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-21

Study Completion Date

2023-08-15

Brief Summary

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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

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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

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized 1:1 study groups
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Metronidazole

Metronidazole 250 mg three times a day

Group Type ACTIVE_COMPARATOR

Metronidazole Oral

Intervention Type DRUG

250 mg Three times a day

Standard care

Standard post-operative care, which may or may not include post-operative antibiotics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Metronidazole Oral

250 mg Three times a day

Intervention Type DRUG

Other Intervention Names

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Flagyl

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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sandykava

Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra Kavalukas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University Surgical Associates

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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20.1054

Identifier Type: -

Identifier Source: org_study_id

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