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Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation

StatusActive, Not Recruiting
PhasePhase 2
Started2023-12-12
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 20, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-07-17
Study Status, Study Design v11
Enrollment increased: 138 → 157 participants
2026-01-08
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations, Document Section v10
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2025-09-15
Study Status v9
Re-verified, no change to tracked fields
2025-03-18
Study Status, References v8
Completion date2026-09-30→2027-03-31
Publicationsdetails revised at 1 of 1 entry
2024-09-19
Study Status, Outcome Measures, Eligibility v7
Eligibility criteria+135 characters
[...] ophosphamide plus calcineurin inhibitor (with or without MMF or sirolimus) One of the following HCT donor types: Human leukocyte anti [...] 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
Secondary endpointsdetails revised at 1 of 4 entries
Show 6 earlier versions
2024-03-12
Study Status, Conditions, Eligibility v6
Start date2023-11-01→2023-12-12
Eligibility criteria+307 characters
[...] ggs/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 [...] ELIGIBILITY CRITERIA FOR RANDOMIZATION: Resolution of all ac [...]
2023-11-13
Study Status, Study Description, Outcome Measures, Eligibility v5
Eligibility criteria+180 characters
[...] w capsules ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade IIIII-IV acute GVHD ELIGIBILITY CRITERIA FOR RANDOMIZATION: No moderate to severe chronic GVHD ELIGIBILITY CRITERIA FOR RANDOMIZATION: No concurrent antibacterial antibiotics except to thosetreat infections. Prophylactic antiviral and antifungal antibiotics used to prevent PCPinfections infectionare as standard of care.allowed Exclusion Criteria: Severe food allergy in the form of anap [...] toms requiring hospitalization History of chronic aspiration or conditions predisposing to aspiration (e.g. neuromuscular disorders) Receiving or planne [...]
Secondary endpoints3 to 4 entries
Chronic GVHD
Study description+1 characters
[...] study intervention, patients are followed up monthly until 18012 daysmonths post-allogeneic HCT.
2023-11-09
Study Status v4
Start dateestimated 2023-12-01→confirmed 2023-11-01
2023-11-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2024-01-01→2023-12-01
Study sitesdetails revised at 1 of 1 site
2023-10-12
2 amendments v1-v2
2 re-verifications since 2023-09-06, no change to tracked fields
2023-08-30
Original filing
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.
Trial Details
NCT Number NCT06026371
Lead Sponsor Fred Hutchinson Cancer Center
Conditions Acute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm
Enrollment 157 participants
Start Date 2023-12-12
Primary Completion 2026-09-30 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-20