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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020091

Enrollment

Registered

2015-12-25

Start date

2015-12-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

1) FMT will be started soon after meeting inclusion criteria. 2) Patient who dose not show sufficient response without severe (grade 3 or higher) adverse events can be offered another course of FMT b

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), or progresses 3 days after initial steroid therapy (steroid-resistant case). Steroid dose can hardly be reduced 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) 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 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.

Design outcomes

Primary

Measure	Time frame
Overall response rate (complete response + partial response) on 28 days after the last FMT.	—

Countries

Japan

Contacts

Public ContactKazuhiko Kakihana

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Hematology division

kakihana@cick.jp+81-3-3823-2101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026