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Completed

NCT Number: NCT04682522

Flagyl Microbiome in Crohn's Disease

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Surgical Associates

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metronidazole Oral

Drug

250 mg Three times a day

Other names: Flagyl

Primary outcomes

  1. Change in bacteria in the gut

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Does the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's Disease

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2020
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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