Allogeneic Hematopoietic Stem CellPhase 2NCT02269150
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study testing fecal microbiota transplantation (FMT) and No fecal microbiota transplantation (FMT), routine management in people with Allogeneic Hematopoietic Stem Cell, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent the future development of CDI. This is also known as fecal bacteriotherapy or stool transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell
- What is being tested?
- fecal microbiota transplantation (FMT) and No fecal microbiota transplantation (FMT), routine management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2027
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned to undergo allo-HSCT
- Age ≥ 18 years
Who cannot join
- As determined by the study investigators or consenting professionals, prolonged antibiotic treatment, as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing antianaerobic antibiotics
- Has severe colitis of any etiology or a history of inflammatory bowel disease (IBD).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Randomized Controlled Trial of Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent the future development of CDI. This is also known as fecal bacteriotherapy or stool transplant.
Read the detailed description
This is a randomized, open-label, controlled study designed to assess the efficacy of autologous fecal microbiota transplantation (auto-FMT) for prevention of Clostridium difficile infection (CDI) in patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). Patients will be enrolled prior to allo-HSCT; feces will be collected and stored from all participating subjects prior to the initiation of conditioning regimens, analyzed by deep 16S rRNA gene sequencing, and tested by assay for intestinal pathogens including Clostridium difficile. Later in the course of transplantation, following engraftment (defined as the first day of three consecutive days, that the absolute blood neutrophil count is at above f 500 mm3), subjects will undergo fecal testing for presence of Bacteroidetes by 16S PCR. Subjects will be eligible for study if they have a microbiologically diverse pre-transplant colonic microbiota, and if the post-engraftment specimen contains Bacteroidetes at a prevalence equal to or below (0.1%)
- Conditions
- Allogeneic Hematopoietic Stem Cell
- Being tested
- fecal microbiota transplantation (FMT), No fecal microbiota transplantation (FMT), routine management
- Keywords
- Recipients, Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiota transplantation (FMT)Biological
No fecal microbiota transplantation (FMT), routine managementOther
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation with pre-transplant feces | Experimental | Prior to transplant hospitalization, store feces for testing and possible future use. Patients undergo fecal microbiota transplantation with the subject's stored pre-transplantation feces. The post-engraftment Bacteroidetes testing, randomization, and fecal microbiota transplantation procedure should all be performed within a 28-day window, beginning on the first day of engraftment. In the event that engraftment occurs prior to day +7, the 28-day window will start on day +7. Subjects from both arms will be followed for one year after transplantation for development of CDI, which will be treated by their BMT clinicians per the standards of care at MSKCC. Subjects from both arms will also be assessed for infections and graft-versus-host disease. During the follow-up period, fecal specimens will be collected serially, if feasible, until one year post randomization and analyzed for microbial diversity and composition. Receives: Biological: fecal microbiota transplantation (FMT) |
| No FMT, routine management | Active comparator | Subjects from both arms will be followed for one year after randomization for development of CDI, which will be treated by their primary BMT clinician per the standards of care at MSKCC. Subjects from both arms will also be assessed by their BMT clinicians for infections and graft-versus-host disease. During the follow-up period, fecal specimens will be collected serially if feasible until one year post randomization and analyzed for microbial diversity and composition. Receives: Other: No fecal microbiota transplantation (FMT), routine management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clostridium difficile infection (CDI)
CDI is defined as diarrheal stool (unformed stool conforming to the shape of a specimen container), and a positive test for toxin-producing C. difficile (either by toxin B gene PCR or cytotoxicity assay).
Measured: up to 1 year following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allogeneic Hematopoietic Stem CellStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Taur, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269150
- Sponsor's protocol ID
- 14-025
- Status last verified
- Nov 2026
- First submitted
- 15 Oct 2014
- Last updated
- 5 Nov 2026
- Results posted
- No
Publications
Taur Y, Jenq RR, Ubeda C, van den Brink M, Pamer EG. Role of intestinal microbiota in transplantation outcomes. Best Pract Res Clin Haematol. 2015 Jun-Sep;28(2-3):155-61. doi: 10.1016/j.beha.2015.10.013. Epub 2015 Oct 22.
PubMed 26590773
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02269150
- Acronym / sponsor ID
- 14-025
- Conditions
- Allogeneic Hematopoietic Stem Cell
- Keywords
- Recipients, Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Oct 2014 (estimated)
- 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.
The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent the future development of CDI. This is also known as fecal bacteriotherapy or stool transplant.
Detailed description
This is a randomized, open-label, controlled study designed to assess the efficacy of autologous fecal microbiota transplantation (auto-FMT) for prevention of Clostridium difficile infection (CDI) in patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). Patients will be enrolled prior to allo-HSCT; feces will be collected and stored from all participating subjects prior to the initiation of conditioning regimens, analyzed by deep 16S rRNA gene sequencing, and tested by assay for intestinal pathogens including Clostridium difficile. Later in the course of transplantation, following engraftment (defined as the first day of three consecutive days, that the absolute blood neutrophil count is at above f 500 mm3), subjects will undergo fecal testing for presence of Bacteroidetes by 16S PCR. Subjects will be eligible for study if they have a microbiologically diverse pre-transplant colonic microbiota, and if the post-engraftment specimen contains Bacteroidetes at a prevalence equal to or below (0.1%)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation with pre-transplant feces | Experimental | Biological: fecal microbiota transplantation (FMT)Prior to transplant hospitalization, store feces for testing and possible future use. Patients undergo fecal microbiota transplantation with the subject's stored pre-transplantation feces. The post-engraftment Bacteroidetes testing, randomization, and fecal microbiota transplantation procedure should all be performed within a 28-day window, beginning on the first day of engraftment. In the event that engraftment occurs prior to day +7, the 28-day window will start on day +7. Subjects from both arms will be followed for one year after transplantation for development of CDI, which will be treated by their BMT clinicians per the standards of care at MSKCC. Subjects from both arms will also be assessed for infections and graft-versus-host disease. During the follow-up period, fecal specimens will be collected serially, if feasible, until one year post randomization and analyzed for microbial diversity and composition. |
| No FMT, routine management | Active comparator | Other: No fecal microbiota transplantation (FMT), routine managementSubjects from both arms will be followed for one year after randomization for development of CDI, which will be treated by their primary BMT clinician per the standards of care at MSKCC. Subjects from both arms will also be assessed by their BMT clinicians for infections and graft-versus-host disease. During the follow-up period, fecal specimens will be collected serially if feasible until one year post randomization and analyzed for microbial diversity and composition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned to undergo allo-HSCT
- Age ≥ 18 years
Key exclusion criteria (2 listed)
- As determined by the study investigators or consenting professionals, prolonged antibiotic treatment, as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing antianaerobic antibiotics
- Has severe colitis of any etiology or a history of inflammatory bowel disease (IBD).
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 microbiota transplantation (FMT) | Biological | Fecal microbiota transplantation with pre-transplant feces |
| No fecal microbiota transplantation (FMT), routine management | Other | No FMT, routine management |
Primary outcome
Clostridium difficile infection (CDI)
Time frame: up to 1 year following randomization
CDI is defined as diarrheal stool (unformed stool conforming to the shape of a specimen container), and a positive test for toxin-producing C. difficile (either by toxin B gene PCR or cytotoxicity assay).
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 5 Nov 2026.
- Derived from this study: PubMed 26590773Taur Y, Jenq RR, Ubeda C, van den Brink M, Pamer EG. Role of intestinal microbiota in transplantation outcomes. Best Pract Res Clin Haematol. 2015 Jun-Sep;28(2-3):155-61. doi: 10.1016/j.beha.2015.10.013. Epub 2015 Oct 22.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Allogeneic Hematopoietic Stem Cell
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
RecruitingPhase 2
Romiplostim for Platelet Engraftment After Haploidentical or Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation
Hematologic Diseases
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. This study is not recruiting at the moment.
Ying Taur, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fecal microbiota transplantation (FMT) and No fecal microbiota transplantation (FMT), routine management in people with Allogeneic Hematopoietic Stem Cell, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clostridium difficile infection (CDI) (time frame: up to 1 year following randomization). 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 NCT02269150, which also lists 1 linked publication.
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 5 Nov 2026.