Phase II. Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Safety as Assessed by Number of Participants With Diarrhea
研究概览
简要总结
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
详细描述
This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. All subjects will be followed for approximately 180 days following FMT for safety.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sexually active female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
- •Female subjects of child-bearing potential must have a negative pregnancy test on the day of the procedure.
- •Subject willing to sign an informed consent form
- •Subject deemed likely to survive for ≥ 1 year after enrollment
- •Able to follow study procedure and follow-ups
- •Subjects' attending physician will provide non-transplant care for the subject
- •Diagnosed by medical history of ≥ 3 bouts of CDI in outpatients or ≥ 2 bouts of recurrent CDI in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin
- •Received at least one course of adequate antibiotic therapy for CDI (≥ 10 days of vancomycin or metronidazole or fidaxomicin) since last bout of CDI
- •Have a 4 degrees Celsius refrigerator at home to keep the second dose FMT for overnight
排除标准
- •Unable to take capsules orally
- •Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT
- •Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other than that found in fortified foods
- •Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT
- •Severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
研究组 & 干预措施
Low fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
干预措施: Low fecal microbiota dose (Biological)
Mid fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
干预措施: Mid fecal microbiota dose (Biological)
High fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
干预措施: High fecal microbiota dose (Biological)
结局指标
主要结局
Safety as Assessed by Number of Participants With Diarrhea
时间窗: 180 days
Safety as Assessed by Number of Participants With Nausea
时间窗: 180 days
Safety as Assessed by Number of Participants With Bloating
时间窗: 180 days
Safety as Assessed by Number of Participants With Constipation
时间窗: 180 days
Safety as Assessed by Number of Participants With Vomiting
时间窗: 180 days
次要结局
- Number of Participants With Recurrent C. Difficile Infection(6 months)
研究者
Herbert DuPont
Professor of Medicine
The University of Texas Health Science Center, Houston