Acute Graft Versus Host DiseasePhase 2NCT06026371
Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation
A Phase 2 study testing Fecal Microbiota Transplantation Capsule in people with Acute Graft Versus Host Disease and Hematopoietic and Lymphatic System Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Fecal Microbiota Transplantation Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to 31 Mar 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
- Age >= 18
- Signed informed consent
- Able to take oral medications
- Planned T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed
- Planned GVHD prophylaxis using one of the following regimens:
- Calcineurin inhibitor (tacrolimus or cyclosporine) plus methotrexate
Show all 23Show fewer
- Calcineurin inhibitor (tacrolimus or cyclosporine) plus mycophenolate mofetil (MMF)
- Sirolimus plus cyclosporine plus MMF
- Post-transplant cyclophosphamide plus calcineurin inhibitor (with or without MMF or sirolimus)
- One of the following HCT donor types:
- Human leukocyte antigen (HLA)-matched sibling donor
- 9/10 or 10/10 HLA-matched unrelated donor
- HLA- haploidentical donor
- Cord blood
- Willing to use at least 1 accepted method of contraception until day 180 after transplant and agree to not donate eggs/sperm for 180 days after
- Not pregnant or breast feeding
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: Absolute neutrophil count (ANC) recovery to > 0.5 x 10^9/L from nadir, without ongoing growth factor support
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: Discontinuation of all antibacterial antibiotics (except those used for Pneumocystis jiroveci prophylaxis) for 2 days
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: Resolution of all acute toxicities (other than anemia and thrombocytopenia) to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or lower
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: Ability to swallow capsules
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade II-IV acute GVHD
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: No moderate to severe chronic GVHD
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: No concurrent antibiotics to treat infections. Prophylactic antiviral and antifungal antibiotics used to prevent infections are allowed
Who cannot join
- Severe food allergy in the form of anaphylaxis or attributable symptoms requiring hospitalization
- History of chronic aspiration or conditions predisposing to aspiration (e.g. neuromuscular disorders)
- Receiving or planned to receive other experimental agents (including ex vivo T-cell depletion) to prevent GVHD. The use of other experimental agents is prohibited unless approved by the principal investigator (PI) of the other trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota transplantation involves receiving processed fecal material orally after allogeneic HCT in order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy administration. Establishing a healthy gut microbiota via fecal transplantation may help prevent acute graft versus host disease in patients undergoing allogeneic HCT.
Read the detailed description
OUTLINE: The first 12 patients are assigned to group I, remaining patients are randomized to 1 of 2 groups.
GROUP I: Patients receive fecal microbiota capsules orally (PO) once daily (QD) for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics.
GROUP II: Patients receive placebo PO QD for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics.
After completion of study intervention, patients are followed up monthly until 12 months post-allogeneic HCT.
- Being tested
- Fecal Microbiota Transplantation Capsule, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation CapsuleDrug
Also called Fecal Microbiota Preparation Delivery Capsule, FMPCapDE, FMT Capsule DE, FMT Capsule Delivery
Given PO
PlaceboDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Group I (fecal microbiota transplant) | Experimental | Patients receive fecal microbiota capsules PO QD for 7 days Receives: Drug: Fecal Microbiota Transplantation Capsule |
| Group II (Placebo) | Placebo comparator | Patients receive placebo PO QD for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade III-IV acute graft versus host disease (GVHD)
Based on International Blood and Marrow Transplantation Research (IBMTR) criteria and measured as a probability
Measured: Up to 6 months post hematopoietic cell transplantation (HCT)
Secondary outcomes (4)
Grade II-IV acute GVHD
Based on IBMTR criteria and measured as a probability
Measured: Up to 180 days post HCT
Non-relapse mortality
Death not due to relapse/progression of the underlying hematologic disorder and measured as a probability
Measured: Up to 180 days post HCT
Clostridium difficile diarrhea
Based on a positive stool assay in the consistent clinical setting (e.g. diarrhea) and measured as a probability
Measured: Up to 180 days post HCT
Chronic GVHD
Diagnosis based on the National Institutes of Health Consensus Criteria (PMID: 25529383)
Measured: At 12 months post-HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start12 Dec 2023
- Primary completion12 Aug 2026
- Study completion31 Mar 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 Acute Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first 12 patients are assigned to the treatment group, remaining patients are randomized to treatment or placebo group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Rashidi, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026371
- Sponsor's protocol ID
- RG1123691
- Other IDs
- NCI-2023-05599, RG1123691, FHIRB0020155
- Status last verified
- Oct 2026
- First submitted
- 30 Aug 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reddi S, Senyshyn L, Ebadi M, Podlesny D, Minot SS, Gooley T, Kabage AJ, Hill GR, Lee SJ, Khoruts A, Rashidi A. Fecal microbiota transplantation to prevent acute graft-versus-host disease: pre-planned interim analysis of donor effect. Nat Commun. 2025 Jan 25;16(1):1034. doi: 10.1038/s41467-025-56375-y.
PubMed 39863610
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT06026371
- Acronym / sponsor ID
- RG1123691
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Sep 2023 (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.
This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota transplantation involves receiving processed fecal material orally after allogeneic HCT in order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy administration. Establishing a healthy gut microbiota via fecal transplantation may help prevent acute graft versus host disease in patients undergoing allogeneic HCT.
Detailed description
OUTLINE: The first 12 patients are assigned to group I, remaining patients are randomized to 1 of 2 groups.
GROUP I: Patients receive fecal microbiota capsules orally (PO) once daily (QD) for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics.
GROUP II: Patients receive placebo PO QD for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics.
After completion of study intervention, patients are followed up monthly until 12 months post-allogeneic HCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The first 12 patients are assigned to the treatment group, remaining patients are randomized to treatment or placebo group.
| Arm | Type | Receives |
|---|---|---|
| Group I (fecal microbiota transplant) | Experimental | Drug: Fecal Microbiota Transplantation CapsulePatients receive fecal microbiota capsules PO QD for 7 days |
| Group II (Placebo) | Placebo comparator | Drug: PlaceboPatients receive placebo PO QD for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age >= 18
- Signed informed consent
- Able to take oral medications
- Planned T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed
- Planned GVHD prophylaxis using one of the following regimens:
Key exclusion criteria (3 listed)
- Severe food allergy in the form of anaphylaxis or attributable symptoms requiring hospitalization
- History of chronic aspiration or conditions predisposing to aspiration (e.g. neuromuscular disorders)
- Receiving or planned to receive other experimental agents (including ex vivo T-cell depletion) to prevent GVHD. The use of other experimental agents is prohibited unless approved by the principal investigator (PI) of the other trial
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 CapsuleAlso: Fecal Microbiota Preparation Delivery Capsule, FMPCapDE, FMT Capsule DE, FMT Capsule DeliveryGiven PO | Drug | Group I (fecal microbiota transplant) |
| PlaceboGiven PO | Drug | Group II (Placebo) |
Primary outcome
Grade III-IV acute graft versus host disease (GVHD)
Time frame: Up to 6 months post hematopoietic cell transplantation (HCT)
Based on International Blood and Marrow Transplantation Research (IBMTR) criteria and measured as a probability
4 secondary outcomes
Grade II-IV acute GVHD
Time frame: Up to 180 days post HCT
Non-relapse mortality
Time frame: Up to 180 days post HCT
Clostridium difficile diarrhea
Time frame: Up to 180 days post HCT
Chronic GVHD
Time frame: At 12 months post-HCT
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 20 Oct 2026.
- Results publication: PubMed 39863610Reddi S, Senyshyn L, Ebadi M, Podlesny D, Minot SS, Gooley T, Kabage AJ, Hill GR, Lee SJ, Khoruts A, Rashidi A. Fecal microbiota transplantation to prevent acute graft-versus-host disease: pre-planned interim analysis of donor effect. Nat Commun. 2025 Jan 25;16(1):1034. doi: 10.1038/s41467-025-56375-y.
- 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.
Armin Rashidi principal investigator
Fred Hutch/University of Washington Cancer Consortium
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 Capsule in people with Acute Graft Versus Host Disease and Hematopoietic and Lymphatic System Neoplasm, run by Fred Hutchinson 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 23 inclusion and 3 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 20 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 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. Some participants in this study may receive a placebo. 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?
Grade III-IV acute graft versus host disease (GVHD) (time frame: Up to 6 months post hematopoietic cell transplantation (HCT)). 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 NCT06026371, 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 20 Oct 2026.