Poop pills may shield stem cell patients from deadly immune attack
NCT ID NCT06026371
First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times
Summary
This study tests whether giving patients a transplant of healthy gut bacteria (from donated stool) can prevent severe graft-versus-host disease (GVHD) after a stem cell transplant. GVHD is a serious complication where donor immune cells attack the patient's body. The trial involves 138 adults receiving a stem cell transplant, and half will get the fecal transplant while the other half gets a placebo. The goal is to see if restoring healthy gut bacteria reduces the risk of severe GVHD.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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157 people
The number who actually took part.
- Started
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Dec 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
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Other studies related to the condition(s) this trial covers.
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