Malignant diseases of the blood system
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Gastrointestinal Acute Graft-versus-Host Disease (GI-aGVHD): 1.Aged between 18 and 70 years. 2.Patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), including peripheral blood stem cell, bone marrow, or cord blood transplantation. 3.Diagnosed with grade II-IV GI-aGVHD according to the NIH consensus criteria. 4.First occurrence of aGVHD. 5.Onset of intestinal aGVHD symptoms occurs between 30 and 100 days post-transplantation. 6.Ability to tolerate oral administration. 7.Signed informed consent form from the patient or their legal representative.
Exclusion criteria
Exclusion criteria: 1. Previous FMT treatment received; 2. Active intestinal infection (such as Clostridioides difficile infection, CMV colitis, etc.); 3. Severe neutropenia (ANC < 0.5×10^9/L); 4. Severe thrombocytopenia (PLT < 20×10^9/L); 5. Severe organ dysfunction (cardiac, hepatic, or renal insufficiency); 6. Recurrence of active malignancy; 7. Pregnant or lactating women; 8. HIV-infected individuals; 9. Allergy to any component in the study protocol; 10. Inability to cooperate with the completion of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-Free Survival; | — |
Countries
China
Contacts
923 Hospital of the Joint Service Support Force of the Chinese People's Liberation Army