Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Poop pills may shield stem cell patients from deadly immune attack

NCT ID NCT06026371

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

157 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute-graft-versus-host disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.