An Exploratory Pilot Study Assessing the Efficacy of Fecal Microbial Transplantation for Clinical and Endoscopic Characteristics of Ileal Pouch Anal Anastomosis Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- safety of fecal microbial transplantation in pouch patients by hospitalizations of patients
研究概览
简要总结
The investigator is hypothesize that an intensive FMT regimen will have superior efficacy the treatment of inflammatory disorders of the pouch (pouchitis and CLDP).
详细描述
Study Design:
An open label non-controlled clinical trial.
Study population:
Patients aged 18 to 80 years with a confirmed diagnosis of UC , who underwent IPAA.
Recruitment of the study population:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80 years with a confirmed diagnosis of UC, who underwent IPAA.
- •Endoscopic deterioration or Clinically suspected pouchitis, defined as increased bowel frequency (≥1 stools) relative to post-IPAA baseline (1-3 months post IPAA).
- •Clinically stable patients on constant medical regimen throughout the study period. Treated by mesalamine for at least 6 weeks, or steroids at least 2 week, or immunomodulator or biologic at least 12 weeks, medical cannabis at least 2 weeks
排除标准
- •Diagnosis of Crohn's disease or indeterminate colitis prior to IPAA.
- •Positive stool test for parasites or stool culture for pathological bacteria within 60 days prior to enrollment.
- •Evidence or history of Clostridium difficile infection within 60 days prior to enrollment.
- •Active clinically significant infection (within 60 days of enrollment).
- •Active septic pouch complication (e.g., abscess, leak, fistula).
- •Post-surgical complication of the pouch (e.g., obstruction, stricture, volvulus, prolapse).
- •Pregnancy or lactation.
- •Unstable or uncontrolled medical disorder (other than suspected pouchitis).
- •Inability to give informed consent and complete the study protocol.
- •Patient participating in other concomitant clinical intervention trial or who had received any experimental drug within a month prior to enrollment
- •Patients received antibiotics within 2 days of enrollment, or are anticipated to use antibiotics or probiotics within the study period (elective surgery or dental care).
- •Patients received fecal transplantation in the last 6 months.
- •Fever>38°c
- •An active malignant disease or a prior malignancy during the previous 5 years (excluding skin BCC).
- •Inability or reluctance to follow through with the study protocol, including (but not exclusive) to: colonoscopy, enema, study visit.
结局指标
主要结局
safety of fecal microbial transplantation in pouch patients by hospitalizations of patients
时间窗: 1 year
determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by amount of patients that require hospitalizations
safety of fecal microbial transplantation in pouch patients by patients requiring surgery
时间窗: 1 year
determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by amount of patients that require surgery
safety of fecal microbial transplantation in pouch patients by disease exacerbations
时间窗: 1 year
determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by rate of patients with disease exacerbations
efficacy of FMT in pouch patients measured by mPDAI decrease
时间窗: 2 months
By preforming a pouchoscopy, mPDAI (modified pouchitis disease activity index) will be used to assess decrease of ≤1 in mPDAI in condition of the pouch comparing to baseline
efficacy of FMT in pouch patients measured by clinical remission
时间窗: 2 months
efficacy of FMT in pouch patients will be measured by the amount of patients with clinical remission measured by mPDAI clinical score \<3
次要结局
- efficacy of FMT in pouch patients measured by amount of patients with sustained remission(12 months)
- efficacy of FMT in pouch patients measured by reduce of inflammatory markers(12 months)
- efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment)(12 months)
- efficacy of FMT in pouch patients measured by amount of patients with sustained clinical remission(12 months)
- efficacy of FMT in pouch patients measured by improvement of life quality(12 months)
- efficacy of FMT in pouch patients measured by improvement of nutritional status(12 months)
研究者
michal roll
Director, R&D Department
Tel-Aviv Sourasky Medical Center