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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole | Active Comparator | Metronidazole 250 mg three times a day |
|
| Standard care | No Intervention | Standard post-operative care, which may or may not include post-operative antibiotics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole Oral | Drug | 250 mg Three times a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Kavalukas, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Surgical Associates | Louisville | Kentucky | 40202 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 6, 2023 | Dec 21, 2023 | 4 | ||
| May 6, 2024 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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Randomized 1:1 study groups
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| Jun 3, 2024 |
| 5 |
| D007410 | Intestinal Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |