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

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Status and phase: Unknown; Phase 2

Conditions: Antibiotic Resistant Strain

Treatments: Other: FMT

Study type: Interventional

Funder types: Other

Identifiers

NCT04593368

NCPHOI-2019-04

Details and patient eligibility

About

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)

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 3 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

FMT

Experimental group

Treatment:

Other: FMT