Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants Evaluated for Infection During Treatment Intervention
研究概览
简要总结
The purpose of this study is to test the safety of FMT in patients with C. difficile and cancer. In previous other studies, FMT has been shown to cure C. difficile when antibiotics have failed, but most of these studies have not included patients with cancer. The investigators want to prove that FMT is safe in this group of people so that doctors will feel more comfortable prescribing it for their patients with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Patients with solid organ malignancy who have received chemotherapy within the past six months.
- •Clinical and microbiologic relapse of C. difficile associated diarrhea after at least one course of adequate antibiotic therapy or refractory disease that does not respond to treatment.
- •At least 10 days of vancomycin at least 125mg QID, or metronidazole 500mg TID
- •C. difficile associated diarrhea is defined as: ≥3 loose or watery stools per day for at least 2 consecutive days or ≥8 loose stools in 48 hours and Positive Clostridium difficile PCR
- •Life expectancy of >3 months.
排除标准
- •Expected prolonged compromised immunity
- •HIV infection with CD4 count <240
- •History of hematopoietic stem cell transplant (HSCT)
- •Hematologic malignancy
- •ANC <1000/mm3
- •Contraindications to anesthesia for procedure
- •Serious cardiopulmonary comorbidities
- •Inability to tolerate anesthesia
- •HGB <8 g/dL
- •Risk of bleeding during procedure
- •PLT <50,000 K/mcL
- •INR >1.5 INR
- •Pregnancy
- •o Pregnant patients will be excluded from this study.
- •Gastrointestinal (GI) contraindications
- •Inflammatory bowel disease
- •Active fistula
- •Small bowel obstruction
- •Gastroparesis
- •Nausea and vomiting
- •Gastrointestinal surgery within the previous 3 months
研究组 & 干预措施
Fecal Microbiota Transplantation (FMT)
Patients with recurrent or refractory CDI who meet study eligibility criteria, will consent to undergo either colonoscopy or upper endoscopy with infusion of stool admixture. Safety will be assessed by monitoring infections that occurred within 2 weeks of the FMT procedures. Additionally, 24-hours, 1 week, 2 weeks, 4 weeks, and 6 months post-FMT, a stool sample will be collected. The time window for each time point listed is +/- 48 hours, with the exception of the first, 24 hour, time point. The time window for the 24 hour time point is +48 hours post FMT.
干预措施: Fecal Microbiota Transplantation (FMT) (Biological)
结局指标
主要结局
Number of Participants Evaluated for Infection During Treatment Intervention
时间窗: 2 weeks after the FMT
Safety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure.
次要结局
未报告次要终点