Status:
ENROLLING_BY_INVITATION
Fecal Microbiota Transplantation Among Adult Patients With Hematological Malignancies
Lead Sponsor:
Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases
Conditions:
Malignant Hematologic Neoplasm
Eligibility:
All Genders
Phase:
NA
Brief Summary
In Hungary - in comparison to other member states of the European Union - about 75000 new cases of cancer are diagnosed annually, from which approximately 4500-5000 patients suffer from so-called mali...
Detailed Description
Fecal microbiota transplantation (FMT) is currently a widely accepted method of manipulating enteric microbiome, and is an internationally recommended procedure in the treatment for Clostridioides (fo...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adult patients (diagnosis age ≥18 years) with malignant hematological disease treated at our center, and
- Capable of giving written informed consent after decision-making, and
- Documented patient colonization with MDR bacterial or fungal isolates, or
- Active C. difficile infection, or
- Patient has undergone autologous or allogeneic hematopoietic stem cell transplantation, or
- Ongoing corticosteroid-refractory acute gastrointestinal GvHD.
- Exclusion criteria (one or more must be met):
- Active bacterial or fungal bloodstream infection requiring antimicrobial therapy, or
- Peripheral blood absolute neutrophil count \<0.5 G/l on ≥7 consecutive days before planned FMT with maximum dose of administered G-CSF, or
- Pressor-refractory septic shock, or
- Major gastrointestinal bleeding within 7 consecutive days before planned FMT, or
- Any pathological process inhibiting successful or safe nasogastric tube insertion, or
- Lack of written informed consent.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07172191
Start Date
October 1 2025
End Date
December 31 2030
Last Update
September 15 2025
Active Locations (1)
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1
South Pest Central Hospital, National Institute of Hematology and Infectious Diseases
Budapest, Budapest, Hungary, H-1097