NCT03061097已完成1 期
Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic rEsistant Bacteria
Microbiome Health Research Institute2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2017年7月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization
研究概览
简要总结
This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety, feasibility and the role of autologous fecal microbiota transplantation (FMT) for the prevention of antibiotic resistant bacteria (ARB) through microbiome restoration.
详细描述
Note: The Protocol and Statistical Analysis Plan document contains modifications from what is on file at the FDA to reflect redactions and formatting requirements for public posting on ClinicalTrials.gov
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for study enrollment
- •Long-term care residents associated with Boston University-Boston Medical Center nursing home consortium
- •Adults (18 years or older)
- •Inclusion criteria for randomization
- •Infection requiring antimicrobial treatment at the discretion of the treating physician
排除标准
- •for study enrollment
- •Pregnant. Participants of childbearing age will undergo urine pregnancy testing
- •Participant or substitute decision maker unable to provide informed consent
- •Allergies to following ingredients generally recognized as safe: glycerol and sodium chloride
- •Current enrollment in hospice
- •Unable to adhere to protocol requirements
- •Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines puts the participant at greater risk from FMT
- •Recent travel (last six months) to high risk regions based on the International SOS Medical Risk Rating system
- •Recent exposure (last six months) to unsafe drinking water
- •Exclusion criteria for stool collection
- •Enrollment stool sample will be tested for ARBs and processed into autologous FMT treatment (if of qualifying size). Sample will not be collected if any of the following are true:
- •Oral or intravenous antibiotic exposure within the previous 6 weeks of stool collection date (topical antibiotics will be permitted)
- •Active gastrointestinal infection at stool collection
- •Fever at the time of stool collection
- •Currently ill or complaining of any of the following signs or symptoms of illness: fever, diarrhea, blood stools and/or vomiting
- •Participants with a history of gastrointestinal (GI) illness within the past 30 days prior to enrollment stool collection, that at the discretion of the site investigator could reasonably be caused by one of the following pathogens: 1) Vibrio spp. 2) Norovirus 3) Rotovirus 4) Adenovirus 5) Shiga toxin
- •Exclusion criteria for randomization
- •Colonized with CRE (assessed by PCR or culture assay during enrollment phase)
- •Colonized with VRE (assessed by PCR or culture assay during enrollment phase)
- •Colonized with ESBL (assessed by PCR or culture assay during enrollment phase)
- •Colonized with CDI (assessed by EIA assay on stool collected at enrollment phase)
- •Treatment with antibiotics which are active against MRSA (i.e. vancomycin or linezolid) prior to randomization to FMT intervention or placebo.
- •Stool culture positive for common enteric pathogens (Salmonella spp., Shigella spp., Campylobacter spp.)
- •Participants who develop a GI illness with symptoms such as (but not limited to) vomiting or diarrhea within 30 days after collection of enrollment stool will be evaluated by the site investigator. If the site investigator determines that the symptoms were most likely caused by 1) Vibrio spp., 2) Norovirus, 3) Rotavirus, 4) Adenovirus, or 5) Shiga toxin, the enrollment stool will be sent out to test for these organisms. If the culture is positive for any of these organisms, the participant will be excluded from randomization
- •Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines puts the participant at greater risk from FMT
- •Participants who become severely immunocompromised, as defined by the investigator or treating physician, will be excluded prior to receiving intervention
结局指标
主要结局
Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization
时间窗: Day 7 after randomization
Number of participants with NIH Grade ≥2 adverse events at Day 7 after randomization.
次要结局
- Number of Patients With Clearance of Antibiotic Resistant Bacteria (ARB)(Day 28 after randomization)
- Number of Participants With NIH Grade ≥2 AEs at Day 28 and Month 6(Day 28, Month 6)
- Number of Participants Who Develop Any ARB-associated Infections(Day 3, Day 7, Day 28, Month 6)
研究者
研究点 (2)
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