Crohn Disease
Conditions
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.
Interventions
250 mg Three times a day
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Randomized 1:1 study groups
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in bacteria in the gut | six months | 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. |
Countries
United States
Outcome results
None listed