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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Antibiotic Resistant Strain

Intervention / Treatment
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* Other: FMT


Participation Criteria
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Eligibility Criteria
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Recipients Inclusion Criteria: 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 Exclusion Criteria: 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) Inclusion Criteria: Age 3-50 years old 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: 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 Therapy with antibiotics less than 3 months before donation Any infection disease revealed during the screening Latent period of infection disease according to the questionnaire Gut disease Longitudinal treatment with drugs Any diet for 3 months before donation. Obesity (BMI ≥ 30).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT<br> | Other: FMT<br>* oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | frequency of decolonization | 7 days after FMT | 
| frequency of SAEs | frequency of SAEs due to FMT | 1 month after FMT | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, hematopoetic stem-cell transplantation, FMT, microbiome