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Tests fecal microbiota transplant in adults with blood cancers

Tests stool transplant to restore gut bacteria in adults with blood cancers.

Plain-language title generated from the registry record
Registry title: Fecal Microbiota Transplantation Among Adult Patients With Hematological Malignancies

Key facts

Where
Budapest, HungarySee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a blood cancer such as leukemia or lymphoma. They must also have a gut bacteria problem or a stem cell transplant. The trial tests stool transplant from a healthy donor.

Age
18 years or older
Sex
Women and men can join
Disease stage
Malignant blood disease (leukemia or lymphoma) treated at the trial center, plus at least one of: known colonization with multidrug-resistant bacteria or fungi; active C. difficile infection; autologous or allogeneic stem cell transplant; ongoing gut graft-versus-host disease (GvHD) that does not respond to corticosteroids
Earlier treatment
Either a stem cell transplant (autologous or allogeneic), or corticosteroid treatment that did not work for acute gut GvHD
Biomarker or test result
Documented colonization with multidrug-resistant bacterial or fungal isolates, or active C. difficile infection

Main reasons for not taking part

  • Active bacterial or fungal bloodstream infection needing treatment
  • Very low neutrophil count (<0.5 G/l) for 7 or more days in a row before the planned stool transplant, despite maximum G-CSF
  • Septic shock that does not respond to pressor drugs
  • Major gut bleeding within 7 days before the planned stool transplant
  • Any problem that stops a safe nasogastric tube insertion

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • How old is the patient who may join a trial?
  • What type of cancer has the patient been diagnosed with?

Source: NCT07172191, who can take part

Where in Hungary

  • South Pest Central Hospital, National Institute of Hematology and Infectious DiseasesBudapest, HungaryNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases
Trial code
NCT07172191
Record updated
30 April 2026
Original description
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.Read full original descriptionShow less

Manipulation of the Enteral Microbiome by Fecal Microbiota Transplantation Among Adult Patients With Malignant Hematological Diseases

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.

Inclusion: 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: Major gastrointestinal bleeding within 7 consecutive days before planned FMT, or; 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; Any pathological process inhibiting successful or safe nasogastric tube insertion, or; Lack of written informed consent.

ClinicalTrials.gov NCT07172191