A Prospective Double Blind Randomized Pilot Study Comparing the Efficacy of Lyophilized Fecal Microbiota Transplantation (FMT) to Lyophilized Sterile Fecal Filtrate in the Management of Recurrent Clostridium Difficile Infection (CDI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Resolution of RCDI
研究概览
简要总结
Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry.
Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).
详细描述
This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.
Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.
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
LFMT and LSFF capsules appear identical. Randomization is performed by lab staff not involved in any aspect of treatment administration or care
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
- •at least 3 episodes of recurrent CDI, with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile toxin, each occurring within 3 months of each other.
- •CDI under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
- •Ability to provide informed consent.
- •Females and males must agree to use effective contraception for the duration of the study as applicable
排除标准
- •Complicated CDI defined as WBC >35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure <90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care.
- •Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
- •Taking or planning to take an investigational drug within 3 months of enrollment.
- •Immunosuppression
- •Chemotherapy or radiation therapy
- •oropharyngeal or significant esophageal dysphagia
- •Ileus or small bowel obstruction
- •Subtotal colectomy
- •Pregnancy or planning to become pregnant within 3 months of enrollment
- •Breastfeeding or planning to breastfeed during the trial
- •Active infection requiring antibiotic therapy.
- •Life expectancy <6 months -
结局指标
主要结局
Resolution of RCDI
时间窗: 8 weeks
Proportion of subjects without RCDI
次要结局
- Resolution of RCDI(24 weeks)
- Difficulty in swallowing capsules(1 week)
- Serious Adverse Events(8 weeks)
- Minor Adverse Events(1 week)
研究者
Dina Kao
Medical Doctor
University of Alberta