Does the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in bacteria in the gut
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-80 years old who is deemed an acceptable surgical candidate for ileocolic resection.
排除标准
- •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
研究组 & 干预措施
Metronidazole
Metronidazole 250 mg three times a day
干预措施: Metronidazole Oral (Drug)
结局指标
主要结局
Change in bacteria in the gut
时间窗: 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.
次要结局
未报告次要终点
研究者
sandykava
Surgeon
University of Louisville