Fecal Microbiome Transplantation (FMT) in Pediatric Patients Colonized With Antibiotic-resistant Pathogens Before Hematopoietic Stem Cell Transplantation (HSCT)
NCT04593368 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2020-12-01
Summary
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)
Conditions
- Antibiotic Resistant Strain
Interventions
- OTHER
-
FMT
oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight
Sponsors & Collaborators
-
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-12-15
- Primary Completion
- 2022-09-30
- Completion
- 2023-09-30
Countries
- Russia
Study Locations
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