Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD (NCT07364617) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD
Taiwan35 participantsStarted 2026-02-01
Plain-language summary
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). GvHD occurs when donor T cells recognize the recipient's tissue as foreign and mount an immune attack against it. Acute GI-GvHD is a common complication following allo-HSCT and a significant cause of mortality. If the initial steroid treatment for acute GvHD fails, mortality rates can reach as high as 81%.
Recent studies have shown a strong association between reduced gut microbiota diversity and high mortality in patients with acute GI-GvHD, highlighting the critical role of the gut microbiome in regulating immune responses and maintaining intestinal homeostasis. Consequently, fecal microbiota transplantation (FMT) has emerged as a potential therapeutic strategy aimed at restoring a healthy gut microbiome and improving clinical outcomes in patients with acute GI-GvHD.
This study aims to evaluate the efficacy and safety of FMT in patients with steroid-refractory or steroid-resistant acute GI-GvHD. The findings of this research will contribute to establishing FMT as a potential and effective treatment option for managing severe acute GI-GvHD, thereby improving patient outcomes and reducing transplant-related mortality.
Who can participate
SexALL
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Inclusion criteria
✓. Stage II to IV steroid refractory acute GI-GvHD in allo-HSCT recipients
✓. 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
✓. 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.
Exclusion criteria
✕. Absolute neutrophil count \< 500 cells/uL.
✕. Absolute platelet count \< 30000 /uL which is not correctable by transfusion
What they're measuring
1
event-free survival
Timeframe: From first fecal microbiota transplantation to the first event or up to 6 months
✕. 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.
✕. Uncontrolled and active infection from bacteria, virus, or fungus as determined by the investigators.