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New treatment option for Graft vs Host Disease
Official title Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD
ClinicalTrials.gov ID: NCT07364617
What this study is testing
What is Fecal microbiota transplantation (FMT)?
Fecal microbiota transplantation (FMT) is an investigational medicine, being studied as a potential treatment for graft vs host disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment for various hematologic diseases. However, one of the major challenges of allo-HSCT is the occurrence of graft-versus-host disease (GvHD), particularly acute gastrointestinal GvHD (GI-GvHD).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Stage II to IV steroid refractory acute GI-GvHD in allo-HSCT recipients
- Stage II to IV acute GI-GVHD people, having \>1000 mL stool per day, diarrhea \> 5 times/day, or abdominal cramping, bleeding or ileus, AND
- Resistant to a first-line therapy with corticosteroids (CS)
- Lack of improvement after 5 days of treatment with CS at 2 mg/kg/d methylprednisolone or other CS with equivalent dose,
- Progression after 3 days of treatment with CS at 2 mg/kg/d methylprednisolone or other CS with equivalent dose.
You likely can't join if
- Absolute neutrophil count \< 500 cells/uL.
- Absolute platelet count \< 30000 /uL which is not correctable by transfusion
- Hemodynamically unstable status with the following conditions: systolic blood pressure \ 22/minute.
- Uncontrolled and active infection from bacteria, virus, or fungus as determined by the investigators.
See the full eligibility criteria
- Stage II to IV steroid refractory acute GI-GvHD in allo-HSCT recipients
- Stage II to IV acute GI-GVHD people, having \>1000 mL stool per day, diarrhea \> 5 times/day, or abdominal cramping, bleeding or ileus, AND
- Resistant to a first-line therapy with corticosteroids (CS)
- Lack of improvement after 5 days of treatment with CS at 2 mg/kg/d methylprednisolone or other CS with equivalent dose,
- Progression after 3 days of treatment with CS at 2 mg/kg/d methylprednisolone or other CS with equivalent dose.
- Age ≥ 18 years old.
- Allo-HSCT with any type of donor, stem cell source, GvHD prophylaxis or conditioning regimen.
- 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.
- 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)
- 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...
- Absolute neutrophil count \< 500 cells/uL.
- Absolute platelet count \< 30000 /uL which is not correctable by transfusion
- Hemodynamically unstable status with the following conditions: systolic blood pressure \ 22/minute.
- Uncontrolled and active infection from bacteria, virus, or fungus as determined by the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taoyuan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.