Autologous Fecal Microbiota Transplantation for Patients With Acute Graft-versus-Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Development of severe adverse events (SAEs) related to autologous FMT
研究概览
简要总结
This study aims to assess the safety and efficacy of autologous fecal microbiota transplantation (FMT) in gastrointestinal (GI) related graft-versus-host disease (GVHD). Stool for FMT will be prepared from pre-allogeneic stem cell transplantation (Allo-SCT) period. This strategy might offer a novel and safe therapeutic approach for these patients, who suffer from high disease related morbidity and mortality and are refractory to multiple treatments.
详细描述
All candidates for Allo-SCT at BMT unit in RHCC will be screened for study inclusion and exclusion criteria. Seven to fourteen days prior to Allo-SCT (before initiation of SCT related antimicrobials), all consenting patients will supply stool sample (first stool sample), which will serve as the autologous FMT sample, and clinical data will be collected. Patients who will develop GI related GVHD will be asked to supply another stool sample 7±2 days after the appearance of GVHD related symptoms (second stool sample). Clinical and laboratory data will be collected. Another stool sample will be collected 7-14 following autologous FMT (third stool sample), and clinical data and outcome will be documented. Day 1 of the study will be defined as day of Allo-SCT, and follow up period is 6 months. Complementary data will be collected from the electronic medical records.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Allo-SCT patients above 18 years of age with acute steroid-resistant GI-related GVHD grade III-IV.
排除标准
- •Prior inclusion to an interventional study
- •Pregnant or lactating women
- •Previous Allo-SCT
- •Known multi-drug resistance carriage prior to stool collection
- •Severe colitis of any etiology or a history of inflammatory bowel disease (IBD)
- •Uncontrolled infection (hemodynamic instability, ongoing fever or bacteremia within 3 days after antibiotics administration)
- •Active GI bleeding
- •Absolute neutrophil count < 500 cells/microL
- •Patients who cannot give informed consent
研究组 & 干预措施
Allo-SCT patients with GI related GVHD
Allo-SCT patients above 18 years of age with acute steroid-resistant GI-related GVHD grade III-IV.
The diagnosis of GVHD will be made on clinical grounds (in line with the major associations' recommendations) - the appearance of characteristic mucoid diarrhea within 100 days after Allo-SCT, with or without associated skin/liver involvement. In cases of atypical presentation - we will recommend biopsy or endoscopy for diagnosis. Patients suspected to have Clostridium difficille associated diarrhea will be tested for toxin (CDT).
Steroid-resistant GI-related GVHD will be defined as lack of improvement (same stage) or worsening of GI symptoms after 7 days of steroid therapy (≥ 2 ml/kg of IV methylprednisolone).
干预措施: Autologous Fecal Microbiota Transplantation (Biological)
结局指标
主要结局
Development of severe adverse events (SAEs) related to autologous FMT
时间窗: 7 days
Development of SAEs related to autologous FMT within 7 days after the intervention. SAEs include mortality, bacteremia, and radiological-proven aspiration pneumonia requiring mechanical ventilation.
次要结局
- Mortality(90 days)
- Change in microbiota composition after each FMT(180 days)
- Complete or partial response of GI-related GVHD after each FMT(90 days)
- Non-severe adverse events (AE)(7 days)
研究者
Haggai Bar-Yoseph MD
Principal investigator
Rambam Health Care Campus