Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Hematologic Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal Microbial Transplantation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FMT
- description
- Patients receiving fecal microbiota transplantation (FMT) for different clinical reasons
- interventionNames
- Biological: Fecal Microbial Transplantation
- type
- NO_INTERVENTION
- label
- non-FMT
- description
- Patients not receiving fecal microbiota transplantation (FMT)
Primary outcomes (1)
- measure
- Disease activity
- timeFrame
- On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls
- description
- Disease activity: hematological remission vs. relapse, GvHD activity. Disease activity of the malignant hematological underlying disease (hematological remission vs. relapse) is defined according to the published methodological recommendations by the National Comprehensive Cancer Network and the European Hematology Association (or the American Society of Hematology, if neither has specific guidance), specifically for each disease. GvHD activity is defined according to the published methodological recommendations of the European Bone Marrow Transplantation Society.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion criteria: 1. Adult patients (diagnosis age ≥18 years) with malignant hematological disease treated at our center, and 2. Capable of giving written informed consent after decision-making, and 3. Documented patient colonization with MDR bacterial or fungal isolates, or 4. Active C. difficile infection, or 5. Patient has undergone autologous or allogeneic hematopoietic stem cell transplantation, or 6. Ongoing corticosteroid-refractory acute gastrointestinal GvHD. Exclusion criteria (one or more must be met): 1. Active bacterial or fungal bloodstream infection requiring antimicrobial therapy, or 2. Peripheral blood absolute neutrophil count \<0.5 G/l on ≥7 consecutive days before planned FMT with maximum dose of administered G-CSF, or 3. Pressor-refractory septic shock, or 4. Major gastrointestinal bleeding within 7 consecutive days before planned FMT, or 5. Any pathological process inhibiting successful or safe nasogastric tube insertion, or 6. Lack of written informed consent.
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Dorina Korózs, Bálint Gergely Szabó, Gábor Apjok et al. · Gut Microbes · Dec 31, 2026 · PMID 42635401 pubmed
- BACKGROUNDDeeg HJ. How I treat refractory acute GVHD. Blood. 2007 May 15;109(10):4119-26. doi: 10.1182/blood-2006-12-041889. Epub 2007 Jan 18. PMID 17234737
- BACKGROUNDPession A, Zama D, Muratore E, Leardini D, Gori D, Guaraldi F, Prete A, Turroni S, Brigidi P, Masetti R. Fecal Microbiota Transplantation in Allogeneic Hematopoietic Stem Cell Transplantation Recipients: A Systematic Review. J Pers Med. 2021 Feb 4;11(2):100. doi: 10.3390/jpm11020100. PMID 33557125
- BACKGROUNDKaito S, Toya T, Yoshifuji K, Kurosawa S, Inamoto K, Takeshita K, Suda W, Kakihana K, Honda K, Hattori M, Ohashi K. Fecal microbiota transplantation with frozen capsules for a patient with refractory acute gut graft-versus-host disease. Blood Adv. 2018 Nov 27;2(22):3097-3101. doi: 10.1182/bloodadvances.2018024968.