Fecal Microbial Transplantation for the Optimization of Vedolizumab Treatment in Patients With Crohn's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- safety of FMT pre vedolizumab treatment in CD patients
研究概览
简要总结
The investigators postulate that by determining a patient's baseline microbiome and manipulating it through fecal microbial transplantation (FMT) may improve response rates to vedolizumab in Crohn's disease (CD) patients.
Primary objective: To determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe and results in higher remission rates in CD patients.
Study design: A randomized double blinded controlled clinical trial. Study population:CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab.
Study procedure: Study participants will receive FMT within a week prior to first vedolizumab infusion.
All patients will be followed for 46 weeks in 8 visits at the IBD clinic in the GI department of the Tel Aviv Medical Center.
详细描述
Study design: A randomized double blinded controlled clinical trial.
Study population:
CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess) will be enrolled in the study.
Follow-up: All patients will be followed by physician assessment, sample collection, anthropometric measurements and questionnaires during the scheduled visits at weeks 2, 6, 14, 22, and at week 46, on which they will undergo a colonoscopic examination as part of their regular clinical followup.
Side effects (SE): will be monitored by phone, 3 days post intervention and at vedolizumab infusion visits at weeks 2 and 6. Also, patients will receive direct contact details of both the study coordinator and the study PI.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients, treating physician and study investigators will be blinded to the treatment intervention (FMT/ placebo).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15
- •Found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess)
排除标准
- •CD patients in remission (HBI<5) or with sever disease (HBI>16)
- •Patients with a stoma
- •Hospitalized patients
- •Patients with an active intestinal infection- positive stool culture or Clostridium difficile infection
- •Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease
- •Pregnant/lactating women
- •Inability to sign an informed consent
- •Inability to complete the study protocol
- •An ongoing or planned antibiotics therapy
- •Severe food allergies
结局指标
主要结局
safety of FMT pre vedolizumab treatment in CD patients
时间窗: week 14
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe. safety of FMT will be measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group.
efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
时间窗: week 46
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in higher remission rates in CD patients. Remission rate will be measured by clinical remission rate HBI ≤5 at week 46
safety of FMT pre vedolizumab treatment in CD patients: measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group
时间窗: week 46
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe. safety of FMT will be measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group.
次要结局
- efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate(week 46)
- efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission(week 46)
- safety of FMT pre vedolizumab treatment in CD patients that results in low adverse events rate(week 46)
- efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic response(week 46)
- efficacy of FMT pre vedolizumab treatment in CD patients that results in histological healing(week 46)
- efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic remission(week 46)
研究者
michal roll
Head of R&D development
Tel-Aviv Sourasky Medical Center