Whey Protein Concentrate 40% (WPC-40) Made of Milk of Immunized Cows to Aid in the Prevention of Relapse of Clostridium Difficile-Diarrhea: A Prospective, Randomized, Controlled Phase II Study - Version 5.1.B
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To investigate the effectiveness of MucoMilk®
研究概览
简要总结
The primary objective of this study is to assess the safety of the investigational agent, MucoMilk®, a polyclonal-antibody enriched Whey Protein Concentrate 40% (WPC-40) made of milk of immunized cows. Secondary objectives will investigate the effectiveness of MucoMilk® as an aid in the prevention of relapse of C. difficile-associated diarrhea (CDAD).
详细描述
This is a single-center, prospective, controlled, randomized, open-label study. Sixty subjects will be randomized 2:1 to receive MucoMilk® (n=40) or to the control arm with no specific product intervention (n=20). There is no effective FDA-approved treatment to prevent recurrence of CDAD that is being withheld from subjects who will be randomized to the control arm.
The sponsor will prepare sequentially numbered batches of MucoMilk® for the entire 2-week dosing period, or 42 packets, and will prepare a randomization table that will be held in confidence by the University of Pittsburgh Investigational Drug Service (IDS) pharmacist. Each subject will be assigned a sequential study number (i.e. 1, 2, 3, etc.) as they are enrolled in the study. Upon enrollment, research staff will contact the IDS pharmacist to obtain the subject's study number and randomization assignment (MucoMilk® or no specific product intervention). Research staff will not have access to the randomization table.
Subjects assigned to receive MucoMilk® will be given a box containing 14 leaflets numbered "Day 1" to "Day 14". Each leaflet consists of 3 packets labeled "morning", "noon", and "evening" connected by perforated paper. Subjects will be provided with one box and instructed not to alter their diet during the two-week course.
At the University of Pittsburgh, it is anticipated that up to 150 subjects will need to be screened in order to enter 60 subjects on study. Subjects may participate in this study for up to 63 days.
Subjects will be managed and followed per institutional infection control guidelines for C. difficile containment regardless of assigned study group. Subjects will receive appropriate treatment for comorbid conditions based on the judgement of the treating physician and practice guidelines. With the exception of investigational agents, any clinically indicated concomitant medications for symptomatic relief or support will be allowed upon recommendation and approval of the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- •Eligible subjects must meet all of the following inclusion criteria:
- •Willingness and ability to comply with all study requirements, to fully understand all elements of informed consent, and to provide written informed consent.
- •Confirmed CDAD by ELISA toxin assay or cell test.
- •Are currently receiving or have received standard antibiotic treatment for CDAD with oral/intravenous metronidazole and/or vancomycin for a minimum of 10 days per standard of care at the discretion of the study physician.
- •Resolution of diarrhea to a maximum of 3 stools per day following completion of antibiotic therapy.
- •Ability to tolerate fluids by mouth or by feeding tube.
- •Have passage of stools.
排除标准
- •Subjects will not be eligible to participate in this study if any of the following exclusion criteria apply:
- •Unable to provide informed consent.
- •History of lactose intolerance.
- •Cannot tolerate fluids by mouth or by feeding tube, or are judged by the attending physician unfit to receive fluids by mouth or by feeding tube.
- •Have received an investigational drug within 4 weeks prior to study entry.
- •Have underlying gastrointestinal tract disease characterized by diarrhea or unformed stools.
- •Are currently receiving any antidiarrheal medications.
- •Current use of an ileostomy or colostomy.
- •History of milk allergy.
- •Current use of Saccharomyces boulardii, Lactinex, or Culturelle preparations at start of study. (S. boulardii is a non-colonizing yeast species purported to support gastrointestinal tract function. It has been widely studied and used to help prevent post-antibiotic diarrhea.)
- •Reside outside of the United States.
- •Cannot speak or read English.
结局指标
主要结局
To investigate the effectiveness of MucoMilk®
次要结局
- To assess the safety of MucoMilk