NCT03106844已完成1 期
The ICON Study: Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection: Outcomes After Fecal Microbiota Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants With FMT Failure
研究概览
简要总结
In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT. The investigators will assess patients before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for recurrence of c.difficile infection and IBD outcomes.
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
- •Adults age 18 or greater
- •Confirmed recurrent CDI by positive PCR or EIA toxin test defined at ≥ 2 episodes and vancomycin failure within one year with the most recent being within the past 3 months.
- •Confirmed diagnosis of IBD with colonic involvement (ulcerative colitis, Crohn's colitis or ileocolitis or indeterminate colitis) for ≥ 3 months
- •Undergoing FMT via colonoscopy for CDI as part of standard medical care
排除标准
- •Unable or unwilling to undergo a colonoscopy
- •Inpatient status
- •Anticipated immediate or upcoming surgery within 30 days
- •Need for continued non-anti-CDI antibiotic therapy
- •History of total or subtotal proctocolectomy
- •Isolated ileal or small bowel disease
- •Pregnancy or lactation
- •Female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months.
- •Patients who are unable to give informed consent
- •Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- •Severe food allergy (anaphylaxis or anaphylactoid-like reaction)
- •Life expectancy < 6 months
- •Unable to adhere to protocol requirements
- •Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT
- •Known concurrent HIV, Hepatitis B or C infection
- •Concurrent PSC
- •Patients with WBC< 3.0 x109th/L at baseline
- •Patients with platelet count < 100 x109th/L
- •Patients with initial elevation of AST or ALT > 1.5 times above normal limit at baseline
- •Non - steroidal anti-inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month
- •Treatment with vancomycin or metronidazole for more then 60 days prior to enrollment
研究组 & 干预措施
Treatment
Experimental
All patients in this study will receive Fecal Microbiota Tranplantation
干预措施: Fecal Microbiota Transplantation (Drug)
结局指标
主要结局
Number of Participants With FMT Failure
时间窗: 8 weeks
Recurrence of c.diffile infection
次要结局
- Participants Colonized With C.Difficile(8 weeks)
研究者
Jessica Ravikoff Allegretti
Principle Investigator
Brigham and Women's Hospital
研究点 (1)
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