Fecal Microbiota Transplantation (FMT) for Immune Checkpoint Inhibitor (ICI)-Related Diarrhea: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Incidence of fecal microbiota transplantation (FMT)-related adverse events
研究概览
简要总结
This study will test the safety, effectiveness, and feasibility of a treatment called fecal microbiota transplantation (FMT) to reduce the symptoms of ICI-related diarrhea.
FMT uses a liquid preparation of stool collected from a healthy donor with normal (healthy) bacteria; this liquid is infused into the small or large intestine of a recipient during a colonoscopy procedure. The study researchers think that the healthy bacteria in the transplanted stool will grow and replace the unhealthy bacteria and return the intestines and colon of the recipient to a healthy state.
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
- •Patient has been treated with immune checkpoint inhibitors (ICI), including anti-CTLA-4, anti-PD-1 and anti-PDL-1 therapy for any malignant indication
- •Patient has developed diarrhea ≥ Grade 2 attributed to ICI
- •Patient has diarrhea ≥ Grade 2 attributed to ICI, that persists despite treatment with corticosteroids for at least 72 hours and/or at least one dose of a biologic medication, such as infliximab or vedolizumab, with symptoms that persist or recur at least 72 hours post-infusion ° If no to the above, patient has a contraindictation to immunosuppressive treatment
排除标准
- •Active GI infection, including untreated viral, bacterial or fungal or alternative identified cause(s) of diarrhea.
- •Antibiotic exposure within 48 hours prior to FMT
- •Expected prolonged compromised immunity indicated by at least one of the below:
- •Known HIV infection with CD4 count <240
- •ANC <1000/mm3 (use of growth factors to raise ANC is acceptable)
- •Seronegative for EBV or CMV (i.e. EBV IgG negative or CMV IgG negative)
- •Contraindications to anesthesia for procedure indicated by at least one of the below:
- •Serious cardiopulmonary comorbidities
- •Inability to tolerate anesthesia
- •Pregnancy
- •Patient is pregnant
- •Women of childbearing potential should not have plans to became pregnant or breastfeed an infant and must agree to use a highly effective method of birth control until 2 months after treatment with FMT (e.g. barrier method, oral or parenteral contraceptives, a vasectomized partner, or abstinence from sexual intercourse)
- •Severe food allergies
研究组 & 干预措施
Fecal Microbiota Transplantation (FMT)
Study subjects will undergo standard bowel preparation and diagnostic colonoscopy with routine biopsies for pathologic assessment. FMT will be performed at the proximal extent of the colon reached, according to the same protocol used in prior randomized studies. FMT will use healthy donor stool provided by OpenBiome, a nonprofit 501(c)(3) organization that provides clinicians and hospitals with screened, filtered and frozen stool to be used for FMT. Routine clinical and research biopsies will be collected during the FMT colonoscopy procedure.
干预措施: Fecal Microbiota Transplantation (FMT) (Biological)
结局指标
主要结局
Incidence of fecal microbiota transplantation (FMT)-related adverse events
时间窗: for 7 days after each FMT
will be grading according to CTCAE 5.0.1
次要结局
未报告次要终点