Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 主要终点
- Resolution of CDI
研究概览
简要总结
Interventional, single arm, single-centre trial to evaluate the effectiveness and safety of fecal microbiota therapy (FMT) in the investigators population.
详细描述
This is a study of the effects of FMT for the treatment of patients with recurrent Clostridium difficile infection (CDI). The investigators plan to enrol approximately 5-10 patients per year over the next 5 years to a maximum of 50 patients. Patients with recurrent CDI referred to the designated Gastrointestinal (GI) or Infectious Diseases (ID) services will be screened for inclusion and exclusion by the primary investigator (PI), sub investigators and/or designated study personnel.
Those patients meeting the criteria will be offered FMT and will be the recipient. An informed consent will be obtained from both the recipient and the donor prior to proceeding with the study protocol. Demographic information as well as details of the medical history and results of standard laboratory tests will be collected on the recipients and donors.
The donor preferably should be < 60 years old to maximize the fecal microbiota. As this does involve biological samples there is a theoretical risk of transmission of an infectious agent. To minimize this risk, the donors will be selected preferentially from a spouse or sexual partner. If this is not possible, then another relative or acquaintance would serve as the donor as identified by the recipient. In either case, the donor will be screened for potentially transmissible infections. This will include a health screening questionnaire adapted from Canadian Blood Services, a clinical examination and laboratory investigations to rule out known transmissible infectious diseases. The donor will complete a satisfaction survey.
The submitted stool will be processed in the lab as per the "Stool Prep Protocol". The route of administration will be by retention enema via a rectal tube. As the treatment is not an emergency the investigators will have the option, if necessary, to store the stool for future treatment. If the sample is not used it will be discarded at 90 days and another sample will be obtained if still required.
Prior to the treatment the recipient will also submit a sample of stool. Along with this a portion of the donor sample will be stored in at -80 degrees C for future molecular tests to determine the diversity of the microbiota. This may be performed at a later date dependent on obtaining the necessary funding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adults aged ≥ 18 yrs of age.
- •Recurrent CDI despite two courses of standard treatment (ie. 10 days of oral vancomycin or metronidazole) and a 6 week taper of oral vancomycin.
- •Laboratory confirmation of CDI by enzyme immunoassay (EIA), cytotoxicity assay and/or polymerase chain reaction (PCR).
- •Presence of persistent diarrhea defined as ≥ 3 loose or watery bowel movements in 24hr continuing for >2 days and diarrhea ongoing at the time of inclusion.
排除标准
- •Severely immunosuppressed patients will not be enrolled. This is defined as >20 mg prednisone/d for >1 month, recent transplant patients (haematological <2yrs and solid organ < 6 months), transplant with active graft versus host disease, HIV (with CD4<200), immunosuppressive antibody treatment (eg. tumour necrosis factor inhibitor, rituximab), other high dose long term systemic immunosuppression) and severe congenital immunodeficiency.
- •Age <18 years old.
- •Patient expected to expire in < 30d.
- •Current hospital admission for an indication other than CDI or need for vasopressor medication.
研究组 & 干预措施
Fecal Microbiota Therapy
Vancomycin 125 mg po qid for 7 days or metronidazole 500 mg po tid for 7 days pre-treatment. Loperamide 4 mg po after morning prep and 2 mg post treatment. The route of administration fecal microbiota will be by retention enema via a rectal tube.
干预措施: Fecal Microbiota (Biological)
Fecal Microbiota Therapy
Vancomycin 125 mg po qid for 7 days or metronidazole 500 mg po tid for 7 days pre-treatment. Loperamide 4 mg po after morning prep and 2 mg post treatment. The route of administration fecal microbiota will be by retention enema via a rectal tube.
干预措施: vancomycin (Drug)
Fecal Microbiota Therapy
Vancomycin 125 mg po qid for 7 days or metronidazole 500 mg po tid for 7 days pre-treatment. Loperamide 4 mg po after morning prep and 2 mg post treatment. The route of administration fecal microbiota will be by retention enema via a rectal tube.
干预措施: Loperamide (Drug)
Fecal Microbiota Therapy
Vancomycin 125 mg po qid for 7 days or metronidazole 500 mg po tid for 7 days pre-treatment. Loperamide 4 mg po after morning prep and 2 mg post treatment. The route of administration fecal microbiota will be by retention enema via a rectal tube.
干预措施: metronidazole (Drug)
结局指标
主要结局
Resolution of CDI
时间窗: 30 days
Resolution of CDI will be defined as \< 3 bowel movements per day for 7 consecutive days or stool negative for Clostridium difficile (CD) on 2 consecutive stool sample at least 1 day apart within 30 days of the treatment.
次要结局
- Success of treatment(3 months)
- Adverse effects(6 months)
- Quality of life(day 0, 3 months and 6 months)
- Recipient Satisfaction(1week, 3 months and 6 months)
- Donor Satisfaction(1 week)
研究者
Dr. Ian Davis
Assistant Professor Department of Medicine, Dalhousie University
Queen Elizabeth II Health Sciences Centre