FMT for Steroid Resistant Gut Acute GVHD

Status Recruiting

Clinical Trial Summary

The study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of steroid resistant graft-versus-host-disease (GVHD) of the gut. This strategy might offer a safe and effective therapeutic approach for these patients with a poor prognosis and limited therapeutic options.

Clinical Trial Description

Graft-versus-host-disease (GVHD) is a major complication after hematopoietic stem cell transplantation (HSCT). Gut is the most vulnerable target organ of acute GVHD. Patients who develope the acute gut GVHD and do not respond to the first line therapy with steroids have a high mortality. The investigation of safe and effective second line therapy for these patients are in need. The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of streoid resistant GVHD of the gut. Stool for FMT will be prepared from the healthy donor.This strategy might offer a safe and effective therapeutic approach for these acute steroid resistant gut GVHD patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04285424
Study type	Interventional
Source	Affiliated Hospital to Academy of Military Medical Sciences
Contact	Min Min, MD
Phone	13426165452
Email	minmin823@sina.com
Status	Recruiting
Phase	Early Phase 1
Start date	March 1, 2020
Completion date	March 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03482154` - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Recruiting	`NCT06080490` - Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients
Completed	`NCT03042676` - Electronic Database for the Follow up of the ATG_FamilyStudy
Recruiting	`NCT03871296` - DNA Methylation in Allogeneic Hematopoietic Stem Cell Transplantation.
Not yet recruiting	`NCT06022445` - Prospective Validation of CARPET Prognostic Model for Septic Shock After Allo-HSCT
Recruiting	`NCT04502628` - Hyperbaric Oxygen Therapy for Hemorrhagic Cystitis Post HSCT	N/A
Recruiting	`NCT03793517` - Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT	Phase 2/Phase 3
Completed	`NCT03454568` - The Patients' Experience After Stem Cell Transplant
Recruiting	`NCT05466201` - The Use of Eltrombopag Post HSCT in BMFS	Phase 2/Phase 3
Not yet recruiting	`NCT04080622` - Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.	Phase 3
Recruiting	`NCT05523336` - Pro-ADM vs PCT in Patients With Complications Post Hematopoietic Stem Cell Transplantation
Completed	`NCT03355235` - Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant
Completed	`NCT04888286` - DSAs in Patients Undergoing Allo-HSCT From Mismatched Donors
Recruiting	`NCT04167683` - Muscle Dysfunction in Patients With Hematological Diseases Referred to Stem Cell Transplant
Active, not recruiting	`NCT03967665` - Risk Stratification-directed NAC for Prevention of Poor Hematopoietic Reconstitution	Phase 3
Withdrawn	`NCT05104268` - Study of a New Medical Device for Oral Mucositis	Early Phase 1
Recruiting	`NCT04623424` - Intestinal Microbiota in Stem Cell Transplant Transplant Admission
Active, not recruiting	`NCT04669210` - PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT	Phase 2
Completed	`NCT03489551` - Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients	Phase 4
Completed	`NCT04106089` - Sleep in Pediatric HSCT	N/A