NCT04593368

Fecal Microbiome Transplantation (FMT) in Pediatric Patients Colonized With Antibiotic-resistant Pathogens Before Hematopoietic Stem Cell Transplantation (HSCT)

Prospective Non-randomized Phase II Clinical Trial of Safety and Efficacy of Fecal Microbiome Transplantation for Pediatric Patients 3-18 Years Old With Confirmed Colonization With Antibiotic-resistant Bacterias and Indication for Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Academic / Other
• Sex: All
• Age: 3 Years – 25 Years
• Healthy volunteers: Accepted

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)

Detailed description

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.

Conditions

• Antibiotic Resistant Strain

Interventions

Type	Name	Description
OTHER	FMT	oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2020-10-20
• Last updated: 2020-12-01

Locations

3 sites across 1 country: Russia