Virus as Treatment of C. Difficile Infection (VISION)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile)
研究概览
简要总结
Fecal Virome Transplantation (FVT) has in small studies shown benefit in the treatment of recurrent C. difficile infection.
In the VISION study we will treat patients with recurrent C. difficile infection with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Both will be following af standard treatment of antibiotics (Vancomycin)
详细描述
In the VISION study we will treat patients with recurrent C. difficile infection (CDI) with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Patients will be randomised to receive either FMT or FTV capsules.
Patients will be followed for one year to investigate the risk of a new recurrence of CDI.
Patients and researchers involved in the treatment of the patients will be blinded to the treatment
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, Investigator, Outcomes Assessor)
盲法说明
Fecal Virome Transplantation and Fecal Microbiota Transplantation capsules will look exactly the same.
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
- •Recurrent C. difficile infection (first or second recurrence)
- •Understand danish
排除标准
- •Serious food allergy (anaphylaxis)
- •Other pathogenic bacteria/virus in stool sample prior to inclusion
- •Inability to ingest capsules
- •Gastrointestinal perforation in the 180 days prior to inclusion
- •Previous treatment with FMT og rectal bacteriotherapy in the 180 days prior to inclusion
- •Short bowel syndrome
- •Pregnancy or planning of pregnancy
- •Participation in other clinical trial in the 30 days prior to inclusion
- •Other condition where FMT is considered contraindicated
结局指标
主要结局
Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile)
时间窗: 8 weeks following treatment
Number of patients in each group (FMT and FVT) with clinical resolution
Participation
时间窗: 1 week after given information about the study
Among patients eligible for treatment how many are interesting in participating in study and potentially receiving new virome treatment
次要结局
- Side effects(Up to eight weeks following treatment)
- Need for rescue Fecal Microbiota Transplantation (FMT)(Up til eight weeks following treatment)
- Long term recurrence of C. difficile infection(Up to one year following treatment)
研究者
Frederik Cold
MD, PhD
Copenhagen University Hospital, Hvidovre