Using fecal microbiota transplantation to prevent acute graft versus host disease in transplant patients
Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
PHASE2 · Fred Hutchinson Cancer Center · NCT06026371
This study is testing if giving fecal microbiota capsules can help prevent severe graft versus host disease in adults who are getting a stem cell transplant.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fred Hutchinson Cancer Center (other) |
| Drugs / interventions | methotrexate, cyclophosphamide, chemotherapy |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06026371 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of fecal microbiota transplantation (FMT) in preventing severe acute graft versus host disease (GVHD) in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Participants will receive either fecal microbiota capsules or a placebo orally for seven days after their neutrophil engraftment and cessation of antibiotics. The study aims to restore a healthy gut microbiota, which is often disrupted during HCT due to various treatments. Patients will be monitored monthly for up to 12 months post-transplant to assess outcomes related to GVHD.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for allogeneic hematopoietic cell transplantation and meet specific eligibility criteria.
Not a fit: Patients who are not undergoing allogeneic hematopoietic cell transplantation or those with contraindications to fecal microbiota transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute graft versus host disease in transplant patients, improving their overall outcomes.
How similar studies have performed: While fecal microbiota transplantation has shown promise in other contexts, this specific application for preventing acute graft versus host disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Armin Rashidi — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Armin Rashidi
- Email: arashidi@fredhutch.org
- Phone: 206-667-2506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm