A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Comparison of microbiome pre and post transplant
研究概览
简要总结
The investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered colonoscopically. The investigators will also characterize the impact of FMT on the microbiota of the recipient and determine if it correlates with the microbiota from the FMT donor.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women, aged 18-65 years old
- •Prior endoscopic confirmation of UC:
- •Mildly to moderately active UC with Simple Clinical Colitis Activity Index (SCCAI) activity index >4-9
- •Failing standard therapy with:
- •stable doses of 5-ASA >2 weeks; thiopurines >3 months; or is steroid dependent at a dose <20mg/d; (inability to taper off steroid for longer than 1 week)
- •Stable medications dose for at least 2 weeks prior to screening and upon entry into trial
- •Ability to understand and willingness to sign informed consent document
排除标准
- •Diagnosis of Crohn's disease, indeterminate colitis, or proctitis alone
- •Severe or fulminate colitis
- •Women who are pregnant or nursing
- •Patients who are unable to give informed consent
- •Patients who are unable or unwilling to undergo colonoscopy
- •Patients who have previously undergone FMT
- •Patients who have a confirmed malignancy or cancer
- •Patients who are immunocompromised
- •Treatment within last 12 weeks with cyclosporine, tacrolimus, infliximab, adalimumab, certolizumab, natalizumab, thalidomide
- •Antibiotic use within 2-months of start date
- •Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- •Probiotic use within 30 days of start date
- •Rectal therapy within 14 days of start date
- •Decompensated cirrhosis
- •Congenital or acquired immunodeficiencies
- •Other comorbidities including:
- •Diabetes mellitus, cancer, systemic lupus, must be able to tolerate conscious sedation with colonoscopy
- •Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 (40)
- •History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia.
- •Steroid >20mg/day
- •Positive screening and confirmatory tests for HIV 1 & 2, Hepatitis A, B, & C, and Syphilis
结局指标
主要结局
Comparison of microbiome pre and post transplant
时间窗: 12 weeks
We will analyze and compare the microbiome (bacterial populations) present pre- and post- transplant of the recipient. We will also analyze the microbiome of the donor and compare it to the donor microbiome pre- and post-FMT.
次要结局
- Tolerance of procedure(day 0 and day 7)
- Adverse event frequency(6 months)