Clinical trial NCT04593368: Fecal Microbiome Transplantation (FMT) in Pediatric Patients Colonized With Antibiotic-resistant Pathogens Before Hematopoietic Stem Cell Transplantation (HSCT)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Antibiotic Resistant Strain
Keywords: pediatric
hematopoetic stem-cell transplantation
FMT
microbiome
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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)

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.

Eligibility criteria: Recipients

Inclusion Criteria:

1. 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
2. Indications for allo-HSCT

Exclusion Criteria:

1. indications for therapy with antibiotics for the next 7 days after FMT
2. Nonstable condition during 1 week before FMT
3. Therapy with antibiotics less than 48 hours before FMT
4. Age less than 3 years
5. Neutrophils count \< 0,5 K/mcL at FMT day and\\or predicted decrease during 2 days after Donors (healthy volunteers)

Inclusion Criteria:

1. Age 3-50 years old
2. Donor choosing order in the absence of contraindications:

1) 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

Exclusion Criteria:

1. Presens of:

   * ESBL Esherihia coli
   * Klebsiella pneumoniae
   * Pseudomonas aeruginosa
   * Clostridium difficile
   * MRSA
   * VRE
   * Streptococcus viridans
   * ESBL Enterobacteriaceae
   * Stenotrophomonas maltophilia
   * Acinetobacter in feces by microbiology culture assay
2. Therapy with antibiotics less than 3 months before donation
3. Any infection disease revealed during the screening
4. Latent period of infection disease according to the questionnaire
5. Gut disease
6. Longitudinal treatment with drugs
7. Any diet for 3 months before donation.
8. Obesity (BMI ≥ 30).

Primary outcomes:
measure: Effectiveness
timeFrame: 7 days after FMT
measure: frequency of SAEs
timeFrame: 1 month after FMT
Secondary outcomes:
measure: Decolonization
timeFrame: 30 days after FMT
measure: acute gut GVHD CI
timeFrame: 100 days after HSCT
measure: Toxicity frequency
timeFrame: 7 days after FMT
measure: Bacteremia
timeFrame: 100 days after FMT
measure: Translocation
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
city: Moscow
country: Russian Federation
facility: Federal Research & Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency
city: Saint Petersburg
country: Russian Federation
facility: RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
Study officials:
References: