Malignant Hematologic NeoplasmHEMAT-FMTNCT07172191

Fecal Microbiota Transplantation Among Adult Patients With Hematological Malignancies

A study testing Fecal Microbial Transplantation in people with Malignant Hematologic Neoplasm, run by Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases at 1 site in Hungary.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: Malignant Hematologic Neoplasm
What is being tested?: Fecal Microbial Transplantation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteHungary
Study dates: 1 Oct 2025to 31 Dec 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hungary1 site

South Pest Central Hospital, National Institute of Hematology and Infectious Diseases
Budapest, Budapest, H-1097

Other trials in Hungary

About this study

Official title: 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.

Read the detailed description

Fecal microbiota transplantation (FMT) is currently a widely accepted method of manipulating enteric microbiome, and is an internationally recommended procedure in the treatment for Clostridioides (formerly Clostridium) difficile (C. difficile) infection. The goal of FMT is to restore physiological gut microbiome through natural competition, by administering a stool graft harvested from a healthy person. FMT not only eliminates C. difficile-induced colitis, but also colonization of multidrug-resistant bacterial/fungal species, and certain types of intestinal epithelial damage occuring in some medical conditions. In recent years due to pleiotropic effects of FMT, scientific interest has turned towards adult patients with malignant hematological diseases, since all of the pathological conditions mentioned earlier occur during clinical care in this population, due to detrimental effects of immuno-chemotherapy. Based on promising preliminary results, FMT could be a successful, easily implementable intervention for these patients in the future.

Therefore, the aim of this study is to perform FMTs in four indication groups among adult patients with malignant hematological diseases treated at South Pest Central Hospital - National Institute of Hematology and Infectious Diseases (Budapest, Hungary), followed by a 180-day follow-up period, during which standardized clinical, laboratory, imaging, and microbiological data are collected. In addition, a high-resolution microbiome analys to monitor microbiological changes of recipient pre-/post-FMT blood and stool samples is planned, in collaboration with Departmental Group of Infectious Diseases and Institute of Medical Microbiology of Semmelweis University (Budapest, Hungary).

This study aims to assess both the bacterial and fungal components of the enteric microbiome in adult patients receiving routine clinical care for malignant hematological diseases, and to explore the potential of manipulating the microbiome through fecal microbiota transplantation (FMT). The hypothesis is that microbiome manipulation with FMT in these patients may induce a successful and sustained response by restoring the physiological intestinal microbiome, a premise that this long-term, comprehensive clinical and microbiological follow-up study seeks to support.

Conditions: Malignant Hematologic Neoplasm
Being tested: Fecal Microbial Transplantation
Keywords: Malignant hematologic neoplasm, Fecal microbiota transplantation
Medical subject headings: Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fecal Microbial TransplantationBiological
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.

Study groups in NCT07172191
Study group	Role	What they receive
FMT	Experimental	Patients receiving fecal microbiota transplantation (FMT) for different clinical reasons Receives: Biological: Fecal Microbial Transplantation
non-FMT	No intervention	Patients not receiving fecal microbiota transplantation (FMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Reducibility of applied immunosuppressive pharmacotherapy. The reducibility of immunosuppressive and antimicrobial pharmacotherapy is determined based on the number of active substances and changes in dose intensity.
Measured: On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls
Reducibility of applied antimicrobial pharmacotherapy
Reducibility of applied antimicrobial pharmacotherapy. The reducibility of immunosuppressive and antimicrobial pharmacotherapy is determined based on the number of active substances and changes in dose intensity.
Measured: On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls
Survival
Survival: total and progression-free survival. Total survival: the patient does not die during the follow-up period. Progression-free survival: during the follow-up period, the stage of the malignant hematological underlying disease documented at enrollment does not change or improves (partial or complete hematological remission occurs), and the patient does not die. The activity of the malignant hematological underlying disease 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.
Measured: On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared controls
Clinical cure of C. difficile infection
Clinical cure of C. difficile infection: we apply the guidelines of the European Society of Clinical Microbiology and Infectious Diseases to define clinical cure
Measured: On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202531 Dec 2030

First posted15 Sep 2025
Study start1 Oct 2025
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Malignant Hematologic NeoplasmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07172191
Sponsor's protocol ID: HEMAT-FMT
Other IDs: 15754-3/2023/EÜIG
Acronym: HEMAT-FMT
Status last verified: Apr 2026
First submitted: 25 Aug 2025
Last updated: 30 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The data that support the findings of this study are available from the corresponding author upon reasonable request. Restrictions apply to the availability of raw patient-level data due to ethical and privacy considerations.

Publications

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.
PubMed 17234737
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.
PubMed 33557125
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.
PubMed 30446486
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.
PubMed 29592876
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.
PubMed 32527171
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.
PubMed 30733264
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.
PubMed 28087657
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.
PubMed 29462280
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.
PubMed 24118601
Korozs D, Szabo BG, Apjok G, Lakatos V, Jeszenszky K, Kamotsay K, Hajbel-Vekony G, Toth A, Sinko J, Remenyi P, Kintses B. Fecal filtrate transplantation as salvage therapy for fulminant Clostridioides difficile infection in adult hematological patients during chemotherapy-induced aplasia: a pilot experience. Gut Microbes. 2026 Dec 31;18(1):2718620. doi: 10.1080/19490976.2026.2718620. Epub 2026 Aug 24.
PubMed 42635401

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Malignant Hematologic Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Manipulation of the Enteral Microbiome by Fecal Microbiota Transplantation Among Adult Patients With Malignant Hematological Diseases
ClinicalTrials.gov ID: NCT07172191
Acronym / sponsor ID: HEMAT-FMT / HEMAT-FMT
Conditions: Malignant Hematologic Neoplasm
Keywords: Malignant hematologic neoplasm, Fecal microbiota transplantation
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 100 participants (estimated)
Lead sponsor: Del-Pest Central Hospital - National Institute of Hematology and Infectious DiseasesUniversity, hospital or other
Study start: 1 Oct 2025 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2030 (estimated)
First posted: 15 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
FMT	Experimental	Biological: Fecal Microbial TransplantationPatients receiving fecal microbiota transplantation (FMT) for different clinical reasons
non-FMT	No intervention	–Patients not receiving fecal microbiota transplantation (FMT)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fecal Microbial TransplantationThe 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.	Biological	FMT

Primary outcome

Disease activity
Time frame: On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls
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.

4 secondary outcomes

Reducibility of applied immunosuppressive pharmacotherapy
Time frame: On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls
Reducibility of applied antimicrobial pharmacotherapy
Time frame: On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls
Survival
Time frame: On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared controls
Clinical cure of C. difficile infection
Time frame: On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
Background: PubMed 17234737Deeg 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.
Background: PubMed 33557125Pession 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.
Background: PubMed 30446486Kaito 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.
Background: PubMed 29592876DeFilipp 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.
Background: PubMed 32527171Biernat 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.
Background: PubMed 30733264Battipaglia 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.
Background: PubMed 28087657Cammarota 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.
Background: PubMed 29462280McDonald 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.
Background: PubMed 24118601Debast 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.
Derived from this study: PubMed 42635401Korozs D, Szabo BG, Apjok G, Lakatos V, Jeszenszky K, Kamotsay K, Hajbel-Vekony G, Toth A, Sinko J, Remenyi P, Kintses B. Fecal filtrate transplantation as salvage therapy for fulminant Clostridioides difficile infection in adult hematological patients during chemotherapy-induced aplasia: a pilot experience. Gut Microbes. 2026 Dec 31;18(1):2718620. doi: 10.1080/19490976.2026.2718620. Epub 2026 Aug 24.
Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author upon reasonable request. Restrictions apply to the availability of raw patient-level data due to ethical and privacy considerations.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease activity (time frame: On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07172191, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.