NCT07172191Enrolling by invitation
Fecal Microbiota Transplantation Among Adult Patients With Hematological Malignancies
Manipulation of the Enteral Microbiome by Fecal Microbiota Transplantation Among Adult Patients With Malignant Hematological Diseases
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Aug 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases
- Diseases
- Childhood cancers
- NCT number
- NCT07172191
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Oct 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major gastrointestinal bleeding within 7 consecutive days before planned FMT, or
Other illness
- Active bacterial or fungal bloodstream infection requiring antimicrobial therapy, or
Lab values
- Peripheral blood absolute neutrophil count \<0.5 G/l on ≥7 consecutive days before planned FMT with maximum dose of administered G-CSF, or
Other
- Pressor-refractory septic shock, or
- Any pathological process inhibiting successful or safe nasogastric tube insertion, or
- Lack of written informed consent.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| South Pest Central Hospital, National Institute of Hematology and Infectious Diseases Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.