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Clinical Trial Summary

Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.


Clinical Trial Description

Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main cause of death after allo-HSCT. Recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-HSCT. On the basis of this theory, fecal microbiota transplantation (FMT) may be an effective method for GVHD, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. In this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04711967
Study type Interventional
Source Qilu Hospital of Shandong University
Contact Shuqian Xu
Phone +86 0531-88382169
Email shuqian.xu@email.sdu.edu.cn
Status Recruiting
Phase N/A
Start date March 10, 2021
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04769895 - MaaT013 as Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients Phase 3
Available NCT04768907 - Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease