Steroid resistant/dependent acute graft-versus-host disease of gut after allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion
Conditions
Interventions
1) FMT using frozen, encapsulated inoculum, will be started soon after meeting inclusion criteria. 2) The minimum dose of FMT: capsules prepared from 30 grams of donor'
s feces. There is no upper limit. 3) Patient who did not show sufficient response without any severe (grade 3 or higher) adverse events can be offered another course of FMT between 3 and 10 days afte
Sponsors
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Acute GVHD of gut after allo-SCT, or DLI. 2)Gut aGVHD does not improve within 5 days after initial steroid therapy (1-2 mg/kg of methylprednisolone, steroid-resistant case), or steroid dose can hardly be reduced less than 0.5 mg/kg of mPSL because of the exacerbation of gut aGVHD (steroid-dependent case). 3) Patients with other comorbid enteropathy can also be enrolled when gut aGVHD is considered as a main cause of their symptoms. 4) Performance status (PS) 0-2 (exclusion: poor PS due to gut aGVHD) 5) Patients with a risk for the insertion of ED tube (e.g. severe thrombocytopenia). 6) Obtained written informed consent from both patient and FMT donor.
Exclusion criteria
Exclusion criteria: 1) Patients who received other systemic therapy, or higher dose of steroid (>2 mg/kg of mPSL) for their aGVHD (exclusion: the use of immunosuppressants for the prophylaxis of GVHD, or topical steroid). 2) Steroid sensitive aGVHD. 3) Progressive aGVHD after steroid therapy. 4) Uncontrollable infection. 5) Patients symptoms are considered to be caused mainly by enteropathy other than gut aGVHD. 6) PS: 3 or higher. 7) With a risk of aspiration. 8) Inadequate condition judged by primary physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of fecal microbiota transplantation using orally administered capsules. All adverse events which newly occurr or progress within 1 week after each FMT are evaluated for the safety of FMT, and are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | — |
Countries
Japan
Contacts
Public ContactKazuhiko Kakihana
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Hematology division
Outcome results
None listed