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

Phase 2

• Conditions: Antibiotic Resistant Strain
• Interventions: Other: FMT

• Registration Number: NCT04593368
• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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.

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-20
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-01
• Study Start: 2020-12-15
• Primary Completion: 2022-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FMT	FMT	-

Primary Outcome Measures

Name	Time	Method
Effectiveness	7 days after FMT	frequency of decolonization
frequency of SAEs	1 month after FMT	frequency of SAEs due to FMT

Secondary Outcome Measures

Name	Time	Method
Decolonization	30 days after FMT	frequency of decolonization
acute gut GVHD CI	100 days after HSCT	CI of gut GVHD
Toxicity frequency	7 days after FMT	frequency of severe toxicity (3-4 grade according to the CTCAE ver 5.0)
Bacteremia	100 days after FMT	frequency of bacteremia
Translocation	1 year	frequency of translocation of pathogens from gut

Trial Locations

Locations (3)

Federal Research & Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency; 🇷🇺 Moscow, Russian Federation

Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology; 🇷🇺 Moscow, Russian Federation

RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University; 🇷🇺 Saint Petersburg, Russian Federation