Efficacy of fecal microbiota transplantation for steroid resistant/ dependent acute graft-versus-host disease of gut, a phase II trial.

Not Applicable

• Conditions: Steroid resistant/dependent acute graft-versus-host disease of gut after allogeneic hametopoietic stem cell transplantation or donor lymphocyte infusion

• Registration Number: JPRN-UMIN000020091
• Lead Sponsor: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-25
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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 of skin or liver 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) Inadequate condition judged by primary physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate (complete response + partial response) on 28 days after the last FMT.