FMT to prevent acute GVHD

In a single-center, randomized, double-blind, placebo-controlled trial, we test the hypothesis that healthy donor oral encapsulated fecal microbiota transplantation (FMT) reduces the incidence of severe acute graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplantation. In the single-arm run-in phase of the trial, we compare 3 stool donors for microbiota and clinical outcomes of their corresponding patients, with the primary focus on microbiota engraftment. Three cohorts of patients each receive FMT from one of the 3 different stool donors. The best of these donors is selected as the sole stool donor for the randomized phase. Quality-filtered host-decontaminated fastq files generated by KneadData are shared. ClinicalTrials.gov identifier: NCT06026371

本项单中心、随机双盲安慰剂对照试验旨在验证如下假说：异基因造血细胞移植术后，接受健康供者口服封装式粪便菌群移植（Fecal Microbiota Transplantation，FMT）可降低重度急性移植物抗宿主病（Graft-versus-Host Disease，GVHD）的发生率。在本试验的单臂导入期阶段，我们将对比3名粪便供者的菌群特征及其对应患者的临床结局，核心观测重点为菌群定植。共设置3组患者，每组分别接受来自3名不同粪便供者的FMT治疗。最终筛选出的最优供者将作为随机对照阶段唯一的粪便供者。本研究共享由KneadData工具生成的经质量过滤并去除宿主序列的fastq格式文件。本试验在ClinicalTrials.gov的登记编号为NCT06026371