Safety of Fecal Microbiota Transplantation: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Short-term Safety of FMT as Measured by Absence or Presence of Related Serious Adverse Events
研究概览
简要总结
The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a prospective, open-label, multi-center longitudinal cohort study to assess the short- and long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools over 24 hours for 2 consecutive days and either a positive stool test for CDI or pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred to one of the study centers after at least three recurrent episodes of CDI and previous treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored for clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical assessment), 8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT. Subjects who recur will be offered a second FMT by colonoscopy with a different donor. Microbiome analysis will be conducted from stool samples at baseline and each of the 5 follow-up intervals.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age 18-75 years old)
- •Outpatient
- •Third or further documented CDI episode and
- •Unable to maintain CDI cure after standard therapy with oral vancomycin or fidaxomicin
- •Previous treatment with at least one course of tapered/pulse vancomycin or
- •Inability to taper or stop vancomycin or fidaxomicin without developing diarrhea requiring antibiotic therapy.
- •Improvement of CDI symptoms on vancomycin or fidaxomicin
排除标准
- •Unable to comply with study follow-up procedures at discretion of MD
- •Unable to provide informed consent at discretion of MD
- •Participating in another clinical trial
- •Pregnant or nursing currently or planned pregnancy in next 1 year
- •Evidence of toxic megacolon or gastrointestinal perforation
- •Peripheral white blood cell count >30 x 10^9/L and/or temperature >38 degrees Celsius
- •Admission to an intensive care unit within prior 7 days for any reason
- •Previously undergone FMT
- •Severely immunocompromised patients
- •HIV infection (any CD4 count)
- •AIDS-defining diagnoses
- •Inherited/primary immune disorder
- •Immunosuppressant medications:
- •Current or recent (<3 months) treatment with anti-neoplastic agents
- •Current or recent (<3 months) treatment with calcineurin inhibitors (tacrolimus, cyclosporine)
- •Current or recent (<3 months) treatment with mycophenolate mofetil
- •Current or recent (<3 months) treatment with monoclonal antibodies to B and T-Cells, anti-TNF, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine)
- •Neutropenia with absolute neutrophil count (ANC) <0.5 x 10^9/L
- •Active gastroenteritis due to infectious cause other than CDI
- •Short gut syndrome
- •Colostomy
- •End-stage liver disease
- •Untreated, in-situ colorectal cancer
- •Irritable bowel syndrome
- •Inflammatory bowel disease including Crohn's disease and ulcerative colitis
- •Microscopic colitis including collagenous colitis and lymphocytic colitis
- •Severe food allergy (anaphylaxis) that cannot be confirmed as having been excluded from a donor's diet within the five days prior to donation
- •Anorectal disorder/severe rectal sphincter tone abnormality or inability to retain enema material
- •Unable or unwilling to tolerate colonoscopy/sigmoidoscopy, colonoscopy prep, or enema for any reason at discretion of MD
- •Severe underlying disease that the patient is not expected to survive for the subsequent 12 months at the discretion of the MD.
- •Any conditions for which, in opinion of MD, the treatment may pose a health risk
研究组 & 干预措施
Intervention: Fecal Microbiota Preparation
Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.
Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor
干预措施: Fecal Microbiota Preparation (Drug)
结局指标
主要结局
Short-term Safety of FMT as Measured by Absence or Presence of Related Serious Adverse Events
时间窗: < 6 weeks post FMT
Determine the short-term safety of FMT for the prevention of further CDI recurrence. Short-term safety was measured by absence or presence of related serious adverse events
Long-term Safety of FMT as Measured by Absence or Presence of Adverse Events
时间窗: > 6 weeks to 1 year post FMT
Determine the long-term safety of FMT for the prevention of further CDI recurrence
次要结局
未报告次要终点