Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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,

Disqualifiers

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 < 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.

Trial design

Treatments tested in this trial

  • Fecal microbiota transplantation (FMT)

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators

Chang Gung Memorial Hospital

Lead sponsor

National Taiwan University Hospital

Collaborator