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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04593368
Other study ID # NCPHOI-2019-04
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date December 15, 2020
Est. completion date September 2023

Study information

Verified date November 2020
Source Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Contact Zhanna Shekhovtsova
Phone 84956647078
Email zhanna.shekhovtsova@fccho-moscow.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
FMT
oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

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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