Last updated: December 1, 2023
Sponsor: Human Biome Institute S.A.
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Fecal Microbiota Transplantation
Clinical Study ID
NCT06156956
HBI/2023/01/STOP-ARB2
Ages > 6 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age > 6 months
- Population of patients colonized with antibiotic-resistant bacteria, as follows:
- strains of antibiotic-resistant bacteria that exhibit resistance mechanisms tocarbapenems (MBL+: NDM+, VIM+ or others), KPC+, OXA-48+ or confirmed resistanceto carbapenems without a specific genetic mechanism
- strains of Enterobacteriaceae resistant to beta lactams and other antibiotics inthe case of multi-drug resistance (e.g. in the ESBL resistance mechanism andothers) of the types including Escherichia, Enterobacter, Klebsiella, strains ofP. aeruginosa, A. baumannii (together included in, among others, the ESKAPEgroup)
- Gram (+) enterococci E. faecalis or E. faecium or other bacteria resistant tovancomycin (VRE), linezolid and strains of S. aureus resistant to methicillin (MRSA) or vancomycin
- other multidrug-resistant or drug-resistant strains with threatening clinicalresistance mechanisms or in patients vulnerable to infection with a particularpathogen
- Absolute neutrophil count in the peripheral blood up to 3 days before FMT > 500/ul (inthe case of tandem multiple FMTs, in patients with an expected decrease in neutrophilvalues, the test should be repeated before each FMT when the timeframe between FMTs islonger than 3 days, and in patients without an expected decrease in the value ofneutrophils below 500 cells/ul peripheral blood counts are valid for 28 days)
- Signing of the informed consent for participation in the study.
Exclusion
Exclusion Criteria:
- Inability to obtain informed consent and lack of consent
- Blood neutrophil count <500/uL on the day of fecal microbiota transplantation orexpected decrease to the mentioned number within 2 consecutive days
- Active infection requiring intensive antimicrobial treatment on FMT day or the first 7days after FMT in immunocompetent patients (without immunosuppression orimmunodeficiency)
- Clinical signs of mucositis 7 days prior to FMT
- Contraindications to FMT via upper and lower gastrointestinal tract (e.g. perforationof the digestive tract, rectal atresia, discontinuity of the digestive tract andothers)
- Severe food allergy with the anaphylaxis history
Study Design
Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Fecal Microbiota Transplantation
Phase:
Study Start date:
October 27, 2023
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Uniwersyteckie Centrum Kliniczne, Klinika Gastroenterologii i Hepatologii
Gdańsk,
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdańsk,
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne, Klinika Pediatrii, Hematologii i Onkologii
Gdańsk,
PolandActive - Recruiting
WOJEWÓDZKI SZPITAL ZESPOLONY W KIELCACH, Klinika Chorób Zakaźnych
Kielce,
PolandActive - Recruiting
WIM-PIB: Klinika Chorób Infekcyjnych i Alergologii, Klinika Gastroenterologii i Chorób Wewnętrznych
Warszawa,
PolandActive - Recruiting
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