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Microbiota Therapy

Fecal Microbiota Transplantation for Graft-versus-Host Disease

Phase 2
Recruiting
Led By Armin Rashidi
Research Sponsored by Fred Hutchinson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade III-IV acute GVHD
Planned T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months post-hct

Summary

This trial tests whether a fecal transplant can help prevent a complication of hematopoietic cell transplants: severe acute graft-vs-host disease. Fecal transplant can help restore a healthy gut microbiota after transplant.

Who is the study for?
Adults undergoing allogeneic hematopoietic cell transplantation for blood cancers can join this trial. They must be able to swallow capsules, not pregnant or breastfeeding, willing to use contraception, and have no severe food allergies or chronic aspiration. Participants should not be on other experimental GVHD prevention agents.
What is being tested?
The study is testing if swallowing fecal microbiota transplantation capsules can prevent severe acute graft versus host disease after a transplant. Half the participants will receive these capsules and half will get a placebo, chosen randomly.
What are the potential side effects?
Potential side effects may include digestive discomfort or changes in bowel habits due to the introduction of new gut bacteria from the fecal transplant capsules.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had severe acute graft-versus-host disease.
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I am scheduled for a stem cell transplant from a donor.
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I am taking tacrolimus or cyclosporine and MMF.
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My donor is almost or fully matched to me.
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All my side effects, except for low red blood cells and platelets, are mild.
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I am not taking any antibiotics, except for preventing PCP as part of my standard care.
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I am taking Sirolimus, Cyclosporine, and MMF.
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I am receiving a specific post-transplant treatment regimen.
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I am taking tacrolimus or cyclosporine with methotrexate.
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I am 18 years old or older.
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I have a sibling donor who is an HLA match.
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My donor is a half-match for my transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months post-hct
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months post-hct for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grade III-IV acute graft versus host disease (GVHD)
Secondary study objectives
Chronic GVHD
Clostridium difficile diarrhea
Grade II-IV acute GVHD
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (fecal microbiota transplant)Experimental Treatment1 Intervention
Patients receive fecal microbiota capsules PO QD for 7 days
Group II: Group II (Placebo)Placebo Group1 Intervention
Patients receive placebo PO QD for 7 days

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor
569 Previous Clinical Trials
1,340,085 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
10 Patients Enrolled for Graft-versus-Host Disease
Armin RashidiPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
~92 spots leftby Sep 2026
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