Poop pills could save lives after stem cell transplants
NCT ID NCT07364617
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether fecal microbiota transplantation (FMT) can help people with severe gut graft-versus-host disease (GvHD) that doesn't respond to steroids. GvHD is a common and dangerous complication after stem cell transplants, where donor cells attack the patient's body. The trial will give FMT to 35 participants to see if it can restore healthy gut bacteria and improve survival.
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
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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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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Feb 2028
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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: 1. Stage II to IV steroid refractory acute GI-GvHD in allo-HSCT recipients 1. Stage II to IV acute GI-GVHD subjects, having \>1000 mL stool per day, diarrhea \> 5 times/day, or abdominal cramping, bleeding or ileus, AND 2. Resistant to a first-line therapy with corticosteroids (CS) <!-- --> 1. Lack of improvement after 5 days of treatment with CS at 2 mg/kg/d methylprednisolone or other CS with equivalent dose, 2. Progression after 3 days of treatment with CS at 2 mg/kg/d methylprednisolone or other CS with equivalent dose. 2. Age ≥ 18 years old. 3. Allo-HSCT with any type of donor, stem cell source, GvHD prophylaxis or conditioning regimen. 4. Allow vancomycin-resistant enterococcus (VRE) colonization and asymptomatic cytomegalovirus (CMV) viremia, which is defined as a detectable CMV viral load in plasma but without tissue-invasive disease. 5. Patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic FMT (antiviral and antifungal agents are allowed) 6. Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship. Subject must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted. Exclusion Criteria: 1. Absolute neutrophil count \< 500 cells/uL. 2. Absolute platelet count \< 30000 /uL which is not correctable by transfusion 3. Hemodynamically unstable status with the following conditions: systolic blood pressure \< 90 mm Hg, pulse oximeter oxygen saturation (SpO2) \< 90%, PaO2 \< 60 mm Hg, or respiratory rate \> 22/minute. 4. Uncontrolled and active infection from bacteria, virus, or fungus as determined by the investigators.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chang Gung Memorial Hospital at Linkou
RECRUITINGTaoyuan, 333423, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stem cell infusions put to the test against a tough transplant complication
- Can a cell injection calm the gut after a stem cell transplant?
- Can a new drug regimen beat the standard for stem cell transplant complications?
- One vitamin a pill before transplant: a new shield against a deadly complication?
- A gentler transplant may cure sickle cell and thalassemia — can the body accept donor cells?
- Can a safer dose of an old drug shield vulnerable children from deadly fungal infections?