Phase II Randomized Clinical Trial of Standard FMT Treatments: Non-powered Pilot Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (RCDI) Using Either Single or Three Combined Products From Healthy Donors
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Safety as assessed by number of participants with treatment-related adverse events
研究概览
简要总结
This is a single center, randomized, parallel assignment, double-blinded, efficacy and safety study to be conducted in subjects with recurrent C. difficile Infection (RCDI). Approximately 200 subjects will be enrolled in the study and randomized at 1:1 ratio to receive lyophilized intestinal bacteria obtained from either single or three donors (group 1 receiving healthy microbiota collected from single donor 90g stool for 2 consecutive days; group 2 receiving healthy microbiota collected from three donors 90g stool for 2 consecutive days). All subjects will be followed for approximately 180 days following FMT treatment for safety.
详细描述
The endpoints of the study are to evaluate the efficacy and safety of lyophilized product by capsules obtained either from single or three donors and the prevention of subsequent bouts of CDI in 60 days post FMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
An independent statistician will develop a randomization list using SAS. Randomization in permuted blocks will be used to achieve balance across treatment groups. The randomization scheme consists of a sequence of blocks such that each block contains a pre-specified number of treatment assignments in random order. The purpose of this is to balance the randomization scheme at the completion of each block. The target sample size is 200 evaluable subjects or as many as can be done up to that number.
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
- •Male and female subjects 18 years of age or older.
- •Sexually active male and female subjects of childbearing potential agree to use an effective method of birth control during the study.
- •Female subjects of childbearing potential will be asked if they could be pregnant. If the subject is unsure a pregnancy test will be completed
- •Subject/LAR willing and able to provide informed consent.
- •Able to follow study procedures and complete the follow-up questionnaire for safety.
- •Subject must have an attending physician who will provide non-transplant care (Either PI of this study or referring physician).
- •Medical history of ≥ 3 bouts of CDI in outpatient or ≥ 2 bouts of CDI in inpatient with either group having ≥ 2 positive fecal tests for C. difficile toxin and at least one bout of CDI within 6 months of enrollment.
- •Received at least two courses of standard-of-care antibiotic therapy for CDI.
排除标准
- •Unable to take capsules orally.
- •Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT.
- •Unwilling to stop taking non-dietary probiotics 24-96 hours prior to FMT.
- •Unable to stop taking bile acid sequestrants (e.g. cholestyramine) 24-96 hours prior to FMT.
- •Unable to stop use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide 24-96 hours prior to FMT and after FMT.
- •Receipt of CDI monoclonal antibodies as treatment for the most recent bout of CDI.
- •Life expectancy of < 6 months.
- •In the opinion of investigator, subject for any reason, should be excluded from the study.
研究组 & 干预措施
Patients with RCDI will receive FMT capsules from single donor
Capsules made with intestinal bacteria from single healthy donor
- st treatment day, lyophilized product generated from single donor (90g of stool)
- nd treatment day, lyophilized product generated from single donor (90g of stool)
干预措施: PRIM-DJ2727 (Drug)
Patient will receive FMT capsules from three donors
Capsules made of intestinal bacteria from three healthy donors
- st treatment day, lyophilized product generated from three donors (90g of stool)
- nd treatment day, lyophilized product generated from three donors (90g of stool)
干预措施: PRIM-DJ2727 (Drug)
结局指标
主要结局
Safety as assessed by number of participants with treatment-related adverse events
时间窗: 60 days
次要结局
未报告次要终点
研究者
Herbert DuPont, MD
Professor of Infectious Diseases
The University of Texas Health Science Center, Houston