Fecal Microbiota Transplantation in Newly Diagnosed Patients With Ulcerative Colitis - a Double Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- UC remission
研究概览
简要总结
Fecal Microbiota Transplantation(FMT) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are associated with gut dysbiosis.
This is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed adult patients with mild-moderate UC.
The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation,in newly diagnosed adult patients with mild-moderate UC.
All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical Center, under GMP conditions.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double Blind (Subject, Caregiver, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after FMT.
- •Ability to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool.
- •Ability to swallow oral medications.
排除标准
- •Severe, uncontrolled ulcerative colitis.
- •Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- •Delayed gastric emptying syndrome
- •Known chronic aspiration
- •Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
- •Pregnant and breast-feeding women
- •Participants who are unable to swallow pills.
研究组 & 干预措施
Fecal transplantation
Fecal transplantation of feces from healthy donor via capsules. Oral application.
干预措施: Fecal transplantation (Other)
Placebo
Placebo capsules
干预措施: Fecal transplantation (Other)
结局指标
主要结局
UC remission
时间窗: 12 weeks
UC remission at week 12 defined as a Simple Clinical Colitis Activity Index\<3
次要结局
- Improvement in UC symptoms(12 weeks)
- Improvement in UC endoscopic score(12 weeks, 6 months and 12 months)
- markers of inflammation(12 weeks, 6 months and 12 months)
- change in gut microbiome(12 weeks, 6 and 12 months.)
- use of treatments for UC(6+12 months)
- Extra-intestinal disease manifestations(6 and 12 month)
研究者
Assaf Harofeh MC
Dr.
Assaf-Harofeh Medical Center