Fecal Microbiota Transplantation Among Adult Patients With Hematological Malignancies
Enrolling by invitation · Not applicable
Conditions studied: Malignant Hematologic Neoplasm
In brief
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 malignant hematological diseases. This disease group includes various leukemias (blood cancers) and lymphomas (lymph node cancers). Chemotherapy for patients with malignant hematological diseases is particularly difficult to bear, as it affects the entire body, including the "good" gut bacteria living inside, and recovery can take several years. Due to the decrease of the "good" gut bacteria during treatment, patients are more prone to acquiring various difficult-to-treat infections, which can lead to deterioration of quality of life, prolonged hospitalization, and in the worst cases, death. The method outlined in this research plan is called fecal microbiota transplantation, during which stool from a healthy person is introduced into the body of the sick patient. The "good" gut bacteria present in the stool then restore the patient's entire gut flora (the process is somewhat similar to the use of probiotics available on the market, but it is a much more effective method). This research aims to assess the success of fecal microbiota transplantation in adults with malignant hematological diseases over a long-term follow-up period, thus contributing to the restoration of their acceptable quality of life.
Key facts
- Study ID
- NCT07172191
- Run by
- Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases
- People needed
- 100
- Starts
- 2025-10-01
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-04-30
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- South Pest Central Hospital, National Institute of Hematology and Infectious Diseases — Budapest, Budapest, Hungary
Full record on ClinicalTrials.gov
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