Graft Versus Host Disease, AcuteNCT04745221
Efficacy and Safety of Auto-FMT in Preventing aGVHD
A study testing Auto-FMT with Standard Prophylaxis and Standard Prophylaxis in people with Graft Versus Host Disease, Acute, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
To evaluation the efficacy and safety of autologous fecal microbiota transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Graft Versus Host Disease, Acute
- What is being tested?
- Auto-FMT with Standard Prophylaxis and Standard Prophylaxis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2021to 19 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years, inclusive.
- Patients with hematologic malignancies indicated for Haplo-HSCT.
- Candidate for myeloablative conditioning and standard GVHD prophylaxis consisting of CsA,MTX, MMF and ATG.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Absence of severe end-organ dysfunction, defined as but not limited to:
- Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥50%;
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- Adequate hepatic function: serum total bilirubin ≤34 µmol/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 × upper limit of normal (ULN);
- Adequate renal function: serum creatinine ≤130 µmol/L.
- Estimated survival of at least 3 months.
- Meet the criteria for autologous fecal microbiota collection:
- No active infection caused by multidrug-resistant (MDR) organisms, and no MDR organism colonization;
- No intake of probiotics or prebiotics within 1 month before fecal microbiota collection;
- No pre-existing chronic gastrointestinal disorders;
- No laboratory abnormalities suggestive of active infection, including screening tests such as procalcitonin (PCT), viral hepatitis serology, T-SPOT, syphilis serology, and human immunodeficiency virus (HIV) testing.
- Able to understand study procedures and voluntarily provide written informed consent; willing and able to adhere to study treatment and follow-up requirements.
Who cannot join
- Prior history of autologous hematopoietic cell transplantation or allogeneic hematopoietic stem cell transplantation.
- Prior documented infection with multidrug-resistant (MDR) organisms.
- Presence of any medical condition that would interfere with study procedures or place the patient at high risk of serious complications, including but not limited to:
- Severe cardiac dysfunction (left ventricular ejection fraction [LVEF] < 50%);
- Abnormal hepatic function: serum total bilirubin > 34 µmol/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN);
- Abnormal renal function: serum creatinine > 130 µmol/L.
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- Known intolerance to auto-FMT.
- Failure to satisfy criteria for post-HSCT FMT administration, defined by any of the following:
- Failure to achieve hematopoietic reconstitution after HSCT;
- Onset of established acute graft-versus-host disease (aGVHD) prior to auto-FMT;
- Uncontrolled active infection;
- Concurrent cytomegalovirus (CMV) or Epstein-Barr virus (EBV) reactivation;
- Clinical conditions that preclude tolerance to auto-FMT, including prominent nausea, vomiting, abdominal pain, diarrhea, intestinal obstruction, gastrointestinal bleeding.
- Pregnant or lactating individuals.
- Dementia or altered mental status that impairs the capacity to provide informed consent.
- Any condition deemed by the investigator to place the patient or study results at unnecessary risk.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: Efficacy and Safety of Autologous Fecal Microbiota Transplantation in Preventing Acute Graft-Versus-Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation: An Open-Label, Randomized Controlled Trial
To evaluation the efficacy and safety of autologous fecal microbiota transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation.
- Conditions
- Graft Versus Host Disease, Acute
- Being tested
- Auto-FMT with Standard Prophylaxis, Standard Prophylaxis
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-FMT with Standard ProphylaxisOther
Also called Cyclosporine(CsA), Methotrexate(MTX), Mycophenolate mofetil(MMF), Anti-thymocyte globulin(ATG)
Autologous fecal microbiota capsules will be administered orally in divided doses post-engraftment with Standard prophylaxis regimen for GVHD after HSCT.
Standard ProphylaxisDrug
Also called Cyclosporine(CsA), Methotrexate(MTX), Mycophenolate mofetil(MMF), Anti-thymocyte globulin(ATG)
Standard prophylaxis regimen for GVHD after HSCT, including CsA,MTX, MMF and ATG.
| Study group | Role | What they receive |
|---|---|---|
| Auto-FMT Group | Experimental | Haplo-HSCT patients will receive autologous fecal microbiota capsules with standard prophylaxis regimen for GVHD after HSCT. Receives: Other: Auto-FMT with Standard Prophylaxis |
| Standard Group | Active comparator | Haplo-HSCT patients will receive standard prophylaxis regimen for GVHD after HSCT. Receives: Drug: Standard Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of grade II-IV aGVHD
Estimated cumulative incidence of grade II-IV aGVHD.
Measured: 100 days after HSCT.
Secondary outcomes (8)
Cumulative incidence of grade Ill-IV aGVHD
Estimated cumulative incidence of grade Ill-IV aGVHD.
Measured: 100 days after HSCT.
Cumulative incidence of chronic graft-versus-host disease(cGVHD)
Estimated cumulative incidence of cGVHD.
Measured: 1 year after HSCT.
Overall survival
Estimated overall survival.
Measured: 1 year after HSCT.
Graft-versus-host disease-free relapse-free survival(GRFS)
Estimated GRFS.
Measured: 1 year after HSCT.
Cumulative incidence of relapse
Estimated cumulative incidence of relapse.
Measured: 1 year after HSCT.
Non-Relapse Mortality(NRM)
Estimated NRM.
Measured: 1 year after HSCT.
Relapse-free survival (RFS)
Estimated RFS.
Measured: 1 year after HSCT.
Grade 3 or higher adverse events
Number of unique patients who had an adverse event that was graded 3 or greater.
Measured: Up to 100 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start27 Aug 2021
- Primary completion27 Aug 2025
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host Disease, AcuteStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Xiao-Fei, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745221
- Sponsor's protocol ID
- FMT2021001
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Autologous Fecal Microbiota Transplantation in Preventing Acute Graft-Versus-Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation: An Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04745221
- Acronym / sponsor ID
- FMT2021001
- Conditions
- Graft Versus Host Disease, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 9 Feb 2021 (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.
To evaluation the efficacy and safety of autologous fecal microbiota transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auto-FMT Group | Experimental | Other: Auto-FMT with Standard ProphylaxisHaplo-HSCT patients will receive autologous fecal microbiota capsules with standard prophylaxis regimen for GVHD after HSCT. |
| Standard Group | Active comparator | Drug: Standard ProphylaxisHaplo-HSCT patients will receive standard prophylaxis regimen for GVHD after HSCT. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Age between 18 and 60 years, inclusive.
- Patients with hematologic malignancies indicated for Haplo-HSCT.
- Candidate for myeloablative conditioning and standard GVHD prophylaxis consisting of CsA,MTX, MMF and ATG.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Absence of severe end-organ dysfunction, defined as but not limited to:
Key exclusion criteria (16 listed)
- Prior history of autologous hematopoietic cell transplantation or allogeneic hematopoietic stem cell transplantation.
- Prior documented infection with multidrug-resistant (MDR) organisms.
- Presence of any medical condition that would interfere with study procedures or place the patient at high risk of serious complications, including but not limited to:
- Known intolerance to auto-FMT.
- Failure to satisfy criteria for post-HSCT FMT administration, defined by any of the following:
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 |
|---|---|---|
| Auto-FMT with Standard ProphylaxisAlso: Cyclosporine(CsA), Methotrexate(MTX), Mycophenolate mofetil(MMF), Anti-thymocyte globulin(ATG)Autologous fecal microbiota capsules will be administered orally in divided doses post-engraftment with Standard prophylaxis regimen for GVHD after HSCT. | Other | Auto-FMT Group |
| Standard ProphylaxisAlso: Cyclosporine(CsA), Methotrexate(MTX), Mycophenolate mofetil(MMF), Anti-thymocyte globulin(ATG)Standard prophylaxis regimen for GVHD after HSCT, including CsA,MTX, MMF and ATG. | Drug | Standard Group |
Primary outcome
Cumulative incidence of grade II-IV aGVHD
Time frame: 100 days after HSCT.
Estimated cumulative incidence of grade II-IV aGVHD.
8 secondary outcomes
Cumulative incidence of grade Ill-IV aGVHD
Time frame: 100 days after HSCT.
Cumulative incidence of chronic graft-versus-host disease(cGVHD)
Time frame: 1 year after HSCT.
Overall survival
Time frame: 1 year after HSCT.
Graft-versus-host disease-free relapse-free survival(GRFS)
Time frame: 1 year after HSCT.
Cumulative incidence of relapse
Time frame: 1 year after HSCT.
Non-Relapse Mortality(NRM)
Time frame: 1 year after HSCT.
Relapse-free survival (RFS)
Time frame: 1 year after HSCT.
Grade 3 or higher adverse events
Time frame: Up to 100 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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?
A study testing Auto-FMT with Standard Prophylaxis and Standard Prophylaxis in people with Graft Versus Host Disease, Acute, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 15 inclusion and 16 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: finished, as of the sponsor's last update on 26 Oct 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative incidence of grade II-IV aGVHD (time frame: 100 days after HSCT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.