Fecal Microbiota Transplantation for Treatment of Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease- a Pilot Study
试验速览
- 阶段
- 1 期
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Serious adverse events
研究概览
简要总结
The investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development and propagation of acute graft-versus-host disease. Therefore, modification of HSCT recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute GVHD.
The study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (ages 18 to 75 years) who underwent allogeneic hematopoietic stem cell transplantation (HSCT) and developed gut acute Graft-versus-Host Disease (aGvHD).
- •Participants have steroid-resistant or steroid-dependent gut aGvHD.
- •Steroid resistant gut aGvHD is defined as cases in which gastrointestinal symptoms do not improve within 7 days after initial steroid therapy (≥1 mg/kg of methylprednisolone) or clear progression after 5 days.)
- •Steroid-dependent gut aGVHD is defined as cases in which reduction of steroid dose was not possible due to exacerbation of gastrointestinal symptoms.
- •Participants may have undergone allogeneic HSCT for any diagnosis at any time prior to developing aGvHD, and are not restricted to any specific conditioning regimen or by the subsequent administration of donor lymphocyte infusion.
- •Participants should be able to give informed consent.
排除标准
- •Participants may not have gut aGvHD which permits the tapering of steroid dose.
- •Participants may not have ongoing, uncontrolled infection (i.e. unresolved bacteremia, uncontrolled CMV infection).
- •Participants may not have ongoing enteritis primarily caused by enteropathy other than gut GvHD, excluding resistant clostridium difficile infection.
- •Participants may not have acute neutrophil count < 500 cells/µL.
- •Participants may not have toxic megacolon
- •Participants may not have active gastrointestinal bleeding.
- •Participants may not be pregnant or lactating.
- •Participants may not be unable to swallow pills.
研究组 & 干预措施
Fecal Microbiota Transplantation (FMT)
Participants will receive a single dose of oral FMT, which is 15 capsules per day for 2 consecutive days (total of 30 capsules). All capsules administered to a participant are from the same unrelated donor. Participants will be asked to fast for 4 hours prior to and 1 hour following capsule intake. Participants will be asked to drink at least 360cc of water during administration.
Treatment will be administered on an inpatient basis. In patients with no/partial response, the FMT may be repeated from the same or a different donor.
Subjects receiving any amount of the FMT capsules will be followed for at least 6 months.Stool and blood samples will be serially collected.
干预措施: Fecal Microbiota Transplantation (Biological)
结局指标
主要结局
Serious adverse events
时间窗: 28 days following FMT.
Participants will be evaluated for serious adverse events (SAEs) relating to FMT occurring within 28 days following transplantation. SAEs are defined as any adverse experience occurring during or after FMT that results in any of the following outcomes: death, life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity or an important medical event events
次要结局
- Gut acute Graft-versus-Host Disease (aGvHD) response.(up to 28 days following FMT.)
- Non-serious adverse events(28 days following FMT.)
- aGvHD severity(up to 28 days following FMT.)
- Reduction in the dose of steroids.(up to 28 days following FMT.)
研究者
Dr. Shouval Roni
Principal Investigator, Hematology and BMT Division
Sheba Medical Center