UnknownPhase 2

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

Russia15 participantsStarted 2020-12-15

Plain-language 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)

Who can participate

Age range3 Years – 25 Years

SexALL

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Inclusion criteria

✓. detection by microbiology culture in any localization species of:
✓. Indications for allo-HSCT

Exclusion criteria

✕. indications for therapy with antibiotics for the next 7 days after FMT
✕. Nonstable condition during 1 week before FMT
✕. Therapy with antibiotics less than 48 hours before FMT
✕. Age less than 3 years
✕. Neutrophils count \< 0,5 K/mcL at FMT day and\\or predicted decrease during 2 days after Donors (healthy volunteers)
✕. Age 3-50 years old
✕. Donor choosing order in the absence of contraindications:
✕. Presens of:

What they're measuring

Effectiveness

Timeframe: 7 days after FMT

frequency of SAEs

Timeframe: 1 month after FMT

Trial details

NCT IDNCT04593368

SponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09

Contact for this trial

Zhanna Shekhovtsova

84956647078 zhanna.shekhovtsova@fccho-moscow.ru

View on ClinicalTrials.gov More Antibiotic Resistant Strain trials