Flagyl Microbiome in Crohn's Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04682522
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Louisville
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sandra Kavalukas, MD
Principal Investigator Affiliation	University of Louisville
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn Disease

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Metronidazole

Metronidazole 250 mg three times a day

No Intervention: Standard care

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

Interventions

Drug: - Metronidazole Oral

250 mg Three times a day

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University Surgical Associates, Louisville, Kentucky

Status

Recruiting

Address

University Surgical Associates

Louisville, Kentucky, 40202

Site Contact

Sandra Kavalukas, MD

sandy.kavalukas@louisville.edu

502-583-8303

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