Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT).
FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability.
Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm.
At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level.
Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 3 month diagnosis of ulcerative colitis
- •Active Colitis disease with endoscopic score >0
- •Ability to sign an informed consent
排除标准
- •Acute neutrophilia (under 500 neutrophils)
- •Clostridium difficile infection
- •Exposure to antibiotics 2 weeks prior to enrollment.
- •Severe immune deficiency
- •Hospitalization
- •Proctitis involving less than 10cm of the rectum
- •Malignancy with the past 5 years (excluding BCC)
- •An unstable dose of steroids or 5ASA (5- aminosalicylic acid) with the past 2 weeks or of immunomodulators or biologic therapy within the past 12 weeks
研究组 & 干预措施
FMT from a healthy donor
Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
- A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
- Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
干预措施: Colonoscopy (Procedure)
FMT from a healthy donor
Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
- A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
- Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
干预措施: Gastroscopy (Procedure)
FMT from a healthy donor
Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
- A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
- Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
干预措施: Fecal Microbiota (Drug)
FMT from a healthy donor
Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
- A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
- Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
干预措施: Enema (Procedure)
FMT from a self donated stool sample
Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
- A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
- Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
干预措施: Colonoscopy (Procedure)
FMT from a self donated stool sample
Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
- A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
- Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
干预措施: Gastroscopy (Procedure)
FMT from a self donated stool sample
Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
- A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
- Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
干预措施: Fecal Microbiota (Drug)
FMT from a self donated stool sample
Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
- A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
- Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
干预措施: Enema (Procedure)
结局指标
主要结局
Clinical improvement
时间窗: 8 weeks after FMT
A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE
次要结局
- Long term remission assessed through questionnaires(one year after FMT)
- Histological remission assessed by sigmoidoscopy(8 weeks after FMT)