Randomized Clinical Trial: Single Versus Multiple-infusion Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Cure of C. difficile infection
研究概览
简要总结
Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves satisfactory cure rates of recurrent CDI). However, several retrospective studies show that severe clinical picture of recurrent CDI is a risk factor for the failure of single-infusion FMT, suggesting that multiple fecal infusions are required to cure this condition.
This is an open-label randomized clinical trial aiming to assess if multiple-infusion FMT is more effective than single-infusion FMT in curing severe CDI
详细描述
Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves satisfactory cure rates of recurrent CDI). However, several retrospective studies show that severe clinical picture of recurrent CDI is a risk factor for the failure of single-infusion FMT, suggesting that multiple fecal infusions are required to cure this condition.
This is an open-label randomized clinical trial aiming to assess if multiple-infusion FMT is more effective than single-infusion FMT in curing severe CDI
The investigators' study is an open-label randomized controlled trial, enrolling patients with recurrent and refractory C. difficile infection with a severe clinical picture of the disease.
At enrollment, C. difficile infection is defined as diarrhoea (at least 3 loose or watery stools per day for 2 or more consecutive days, or at least 8 loose stools in 48 hours) and positivity in the C. difficile toxin stool test.
Recurrent C. difficile infection is meant as the reappearance of clinical symptoms and positivity of C. difficile toxin test within 8 weeks after the end of the previous therapy.
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
- 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
- 未提供
排除标准
- •Subjects <18 years old
- •Prior colectomy
- •Negativity of C. difficile toxin in stools
- •Mild clinical picture of C. difficile infection
- •High risk of post-colonoscopy complications
- •Other main gastrointestinal diseases (es. Crohn's disease or ulcerative colitis)
- •Stool positivity for parasites
- •Stool positivity for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms except for C. difficile
- •Blood positivity for: Hepatitis A virus-Immunoglobulin M, HBsAg, Anti-Hepatitis C Virus, Anti-Human Immunodeficiency Virus1-2, venereal disease reaction level (VDRL).
- •Pregnancy or breastfeeding.
- •Inability to follow protocol procedures
研究组 & 干预措施
Multiple-infusion FMT
Repeated fecal infusions by colonoscopy. Before FMT, vancomycin is administered in all patients for 3 days
干预措施: Vancomycin (before randomization) (Drug)
Multiple-infusion FMT
Repeated fecal infusions by colonoscopy. Before FMT, vancomycin is administered in all patients for 3 days
干预措施: multiple-infusion FMT (Biological)
Single-infusion FMT
Single fecal infusion by colonoscopy.Before FMT, vancomycin is administered in all patients for 3 days
干预措施: Single-infusion FMT (Biological)
Single-infusion FMT
Single fecal infusion by colonoscopy.Before FMT, vancomycin is administered in all patients for 3 days
干预措施: Vancomycin (before randomization) (Drug)
结局指标
主要结局
Cure of C. difficile infection
时间窗: 8 weeks
Disappearance of C. difficile-associated diarrhea
次要结局
未报告次要终点
研究者
Giovanni Cammarota
Associate Professor of Gastroenterology
Catholic University of the Sacred Heart