NCT03268213已完成1 期
Fecal Microbial Transplantation in Patients With Medication Refractory Clostridium Difficile and/or Ulcerative Colitis or Indeterminate Colitis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
Fecal Microbiota Transplantation will be offered to eligible C. difficile patients (does not require Investigational New Drug designation) and to eligible ulcerative colitis or indeterminate colitis patients as Investigational New Drug treatment
详细描述
The following hypothesis will be tested in this study:
- Fecal microbiota transplantation is a safe, tolerable, and efficacious procedure for C. difficile patients and is a safe and tolerable procedure for ulcerative colitis and indeterminate colitis patients.
- The fecal microbial diversity, composition and function in stool recipients after fecal transplantation will change to a similar microbial diversity, composition and functionality as found in donor stool.
Primary objectives:
- To determine the short term safety and tolerability of fecal microbiota transplantation in patients with recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or indeterminate colitis up to 12 weeks post-transplant.
Secondary objectives:
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
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For C. difficile patients/recipients only:
- •Patient is 7 years of age or older.
- •One of the following: 2a. At least two recurrences (total three CDI infections) of mild to moderate C. difficile (<6 diarrheal stools/day) diagnosed by positive toxin PCR or EIA after completing standard medical therapy with metronidazole, vancomycin or fidaxomicin.
- •2b. At least two episodes of severe C. difficile infection (>6 diarrheal stools/day requiring hospitalization and associated with significant morbidity).
- •2c. Moderate C. difficile infection (3-6 diarrheal stools/day not responding to successive standard therapy, e.g. metronidazole, vancomycin and/or fidaxomicin) lasting at least 28 days.
- •2d. Severe and/or fulminant C. difficile colitis (> 6 diarrheal stools/day) with no response to standard therapy after 48 hours.
排除标准
- •younger than 7 year old
- •scheduled for abdominal surgery within the next 12 weeks
- •had major abdominal surgery within the past 3 months
- •Hemoglobin < 6 g/dL
- •absolute neutrophil count less than 1500/mm3
- •known diagnosis of graft vs. host disease
- •used an investigational drug within the past 2 months
- •used a TNFα agonist within the past 2 weeks
- •diagnosed with Bacteremia within the past 4 weeks
- •For patients with ulcerative and indeterminate colitis only:
- •Patient is 7 years of age or older.
- •One of the following:
- •2a. treated with steroid therapy for at least one month. 2b. treated with immunomodulatory therapy for at least one month 2c. treated with biological therapy for at least one month.
- •younger than 7 years old
- •scheduled for abdominal surgery within the next 12 weeks
- •had major abdominal surgery within the past 3 months
- •Hemoglobin < 6 g/dL
- •absolute neutrophil count less than 1500/mm3
- •known diagnosis of graft vs. host disease
- •used an investigational drug within the past 2 months
- •used a TNFα agonist within the past 2 weeks
- •diagnosed with Bacteremia within the past 4 weeks
- •previous FMT
研究组 & 干预措施
Fecal microbial transplantation
Experimental
Treated with fecal microbial transplantation
干预措施: Fecal Microbial Transplantation (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 9 years
Number of participants with treatment-related adverse events with grade greater than 2 within one year after FMT will be reported. Safety will be assessed as a report of no new medical condition after the transplant, Tolerability, as recorded by report of no serious adverse events after the transplant and Efficacy of the procedure will be recorded as improvement in clinical symptoms during any clinically indicated colonoscopies after the transplant as compared to before transplant C. Diff patients will have a negative C. diff test report after the transplant as an out come measure.
次要结局
- Determine number of C. difficile recipients who have recurrent C. difficile within a year after fecal microbial transplant(10 years)
- To measure the effect of fecal microbial transplantation on microbial diversity in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools.(10 years)
- To measure the effect of fecal microbial transplantation on microbial composition in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools.(10 years)
- To measure the effect of fecal microbial transplantation on microbial function using bacterial metatranscriptomic sequencing(10 years)
- To measure the effect of fecal microbial transplantation on microbial function using shotgun DNA metagenomic in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools.(10 years)
- Determine if FMT causes a statistically significant change in recipient fecal calprotectin levels(10 years)
- To measure the effect of fecal microbial transplantation on microbial function using targeted metabolomic assays.(10 years)
研究者
Anupama Chawla
Professor
Stony Brook University
研究点 (1)
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