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

NCT04593368 | Unknown Phase 2

• 1 other identifier: NCPHOI-2019-04
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

pediatric; hematopoetic stem-cell transplantation; FMT; microbiome

Outcome Measures

Primary Outcomes (2)

• Effectiveness

  frequency of decolonization

  7 days after FMT

• frequency of SAEs

  frequency of SAEs due to FMT

  1 month after FMT

Secondary Outcomes (5)

• Decolonization

  30 days after FMT

• acute gut GVHD CI

  100 days after HSCT

• Toxicity frequency

  7 days after FMT

• Bacteremia

  100 days after FMT

• Translocation

  1 year

Study Arms (1)

FMT

EXPERIMENTAL

Other: FMT

Interventions

FMT OTHER

oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight

FMT

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• detection by microbiology culture in any localization species of:
• Pseudomonas aeruginosa
• Clostridium difficile
• Vancomycin-resistant Enterococcus
• Streptococcus viridans
• ESBL Enterobacteriaceae, including Escherichia coli and Klebsiella pneumoniae
• Stenotrophomonas maltophilia
• Acinetobacter
• Methicillin-resistant Staphylococcus aureus
• Indications for allo-HSCT

You may not qualify if:

• 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:
• \) HLA-match/mismatch HSCT family donor; 2) Closest family relative with whom the recipient lives; 3) Unrelated healthy volunteer from the FRCC PCM bank of frozen transplants
• Presens of:
• ESBL Esherihia coli
• Klebsiella pneumoniae
• Pseudomonas aeruginosa
• Clostridium difficile
• MRSA
• VRE

Sponsors & Collaborators

• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: lead

Study Sites (3)

Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology

Moscow, 117198, Russia

Location

Federal Research & Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency

Moscow, 119435, Russia

Location

RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University

Saint Petersburg, 197022, Russia

Location

Central Study Contacts

Zhanna Shekhovtsova

CONTACT

84956647078; zhanna.shekhovtsova@fccho-moscow.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: December 15, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)