Fecal Microbiota Transplantation Among Adult Patients With Hematological Malignancies

NCT07172191 | Enrolling By Invitation

• 2 other identifiers: HEMAT-FMT15754-3/2023/EÜIG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Malignant Hematologic Neoplasm

Keywords

Malignant hematologic neoplasm; Fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• Disease activity

  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.

  On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls

Secondary Outcomes (4)

• Reducibility of applied immunosuppressive pharmacotherapy

  On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls

• Reducibility of applied antimicrobial pharmacotherapy

  On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls

• Survival

  On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared controls

• Clinical cure of C. difficile infection

  On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls

Other Outcomes (4)

• Loss of colonization with multidrug-resistant bacterial or fungal isolates

  On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls

• Loss of C. difficile colonization

  On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls

• Regeneration of blood and gut microbiome after autologous and allogeneic stem cell transplantation

  On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls

Study Arms (2)

FMT

EXPERIMENTAL

Patients receiving fecal microbiota transplantation (FMT) for different clinical reasons

Biological: Fecal Microbial Transplantation

non-FMT

NO INTERVENTION

Patients not receiving fecal microbiota transplantation (FMT)

Interventions

Fecal Microbial Transplantation BIOLOGICAL

The technical implementation of FMT procedure is consistent with the methodological letter issued by the National Public Health Center of Hungary. FMT is performed via nasogastric tube with suspended fresh stool graft or fecal filtrate, or lyophilised stool capsules, obtained and prepared from a pre-selected stool donor. Following FMT, the patient is observed for 24 hours at our center. The process is supervised and performed by the lead researcher.

FMT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases: lead

Study Sites (1)

South Pest Central Hospital, National Institute of Hematology and Infectious Diseases

Budapest, Budapest, H-1097, Hungary

Location

Related Publications (9)

• Deeg 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 BACKGROUND

• Pession 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 BACKGROUND

• Kaito 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.

  PMID: 30446486 BACKGROUND

• DeFilipp Z, Peled JU, Li S, Mahabamunuge J, Dagher Z, Slingerland AE, Del Rio C, Valles B, Kempner ME, Smith M, Brown J, Dey BR, El-Jawahri A, McAfee SL, Spitzer TR, Ballen KK, Sung AD, Dalton TE, Messina JA, Dettmer K, Liebisch G, Oefner P, Taur Y, Pamer EG, Holler E, Mansour MK, van den Brink MRM, Hohmann E, Jenq RR, Chen YB. Third-party fecal microbiota transplantation following allo-HCT reconstitutes microbiome diversity. Blood Adv. 2018 Apr 10;2(7):745-753. doi: 10.1182/bloodadvances.2018017731.

  PMID: 29592876 BACKGROUND

• Biernat MM, Urbaniak-Kujda D, Dybko J, Kapelko-Slowik K, Prajs I, Wrobel T. Fecal microbiota transplantation in the treatment of intestinal steroid-resistant graft-versus-host disease: two case reports and a review of the literature. J Int Med Res. 2020 Jun;48(6):300060520925693. doi: 10.1177/0300060520925693.

  PMID: 32527171 BACKGROUND

• Battipaglia G, Malard F, Rubio MT, Ruggeri A, Mamez AC, Brissot E, Giannotti F, Dulery R, Joly AC, Baylatry MT, Kossmann MJ, Tankovic J, Beaugerie L, Sokol H, Mohty M. Fecal microbiota transplantation before or after allogeneic hematopoietic transplantation in patients with hematologic malignancies carrying multidrug-resistance bacteria. Haematologica. 2019 Aug;104(8):1682-1688. doi: 10.3324/haematol.2018.198549. Epub 2019 Feb 7.

  PMID: 30733264 BACKGROUND

• Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.

  PMID: 28087657 BACKGROUND

• McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, Dubberke ER, Garey KW, Gould CV, Kelly C, Loo V, Shaklee Sammons J, Sandora TJ, Wilcox MH. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):e1-e48. doi: 10.1093/cid/cix1085.

  PMID: 29462280 BACKGROUND

• Debast SB, Bauer MP, Kuijper EJ; European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014 Mar;20 Suppl 2:1-26. doi: 10.1111/1469-0691.12418.

  PMID: 24118601 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Ph.D.

Model Details: Eligible patients for inclusion are stratified into different interventional subgroups based on four differenc clinical indications for FMT as intervention: 1. patient group: elimination of documented MDR colonization, 2. patient group: treatment of active C. difficile infection, 3. patient group: enteral microbiome restoration following autologous and allogeneic hematopoietic stem cell transplantation, 4. patient group: treatment of corticosteroid-refractory acute gastrointestinal GvHD (see later). Control groups not receiving FMT as intervention are selected either: 1) from patients who possess the same clinical severity/stage and clinical indication for FMT, but do not agree to participate in the study or not eligible for technical reasons, or 2) randomly selected from patients without malignant hematological diseases and are hospitalized at our center. Patient recruitment is conducted consecutively, and a 1:2 ratio for case-control matching is followed during inclusion.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)