a clinical trial designed to prospectively assess the safety and effectiveness of fecal microbiota transplantation (FMT) prior to allogeneic hematopoietic stem-cell translation (HSCT) in patients contaminated with antibiotic-resistant pathogens (ARP)
The investigator's question is whether FMT decontaminates ARP and as a result, decreases the risk of severe infection which leads to transplant-related morbidity and mortality after HSCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
15
oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Moscow, Russia
Federal Research & Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency
Moscow, Russia
RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
Saint Petersburg, Russia
Effectiveness
frequency of decolonization
Time frame: 7 days after FMT
frequency of SAEs
frequency of SAEs due to FMT
Time frame: 1 month after FMT
Decolonization
frequency of decolonization
Time frame: 30 days after FMT
acute gut GVHD CI
CI of gut GVHD
Time frame: 100 days after HSCT
Toxicity frequency
frequency of severe toxicity (3-4 grade according to the CTCAE ver 5.0)
Time frame: 7 days after FMT
Bacteremia
frequency of bacteremia
Time frame: 100 days after FMT
Translocation
frequency of translocation of pathogens from gut
Time frame: 1 year
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