Antibiotic Resistant Strain Clinical Trial
— FMT-HSCTOfficial 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
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)
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | September 2023 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 25 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology | Moscow | |
Russian Federation | Federal Research & Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency | Moscow | |
Russian Federation | RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness | frequency of decolonization | 7 days after FMT | |
Primary | frequency of SAEs | frequency of SAEs due to FMT | 1 month after FMT | |
Secondary | Decolonization | frequency of decolonization | 30 days after FMT | |
Secondary | acute gut GVHD CI | CI of gut GVHD | 100 days after HSCT | |
Secondary | Toxicity frequency | frequency of severe toxicity (3-4 grade according to the CTCAE ver 5.0) | 7 days after FMT | |
Secondary | Bacteremia | frequency of bacteremia | 100 days after FMT | |
Secondary | Translocation | frequency of translocation of pathogens from gut | 1 year |
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