Safety of fecal microbiota transplantation for steroid-refractory/dependent acute graft-versus-host disease of the gut, a phase I trial

Safety of fecal microbiota transplantation for steroid-refractory/dependent acute graft-versus-host disease of the gut, a phase I trial - Safety of FMT for acute gut GVHD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053473

Enrollment

Registered

2024-02-01

Start date

2023-12-05

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 refractory/dependent acute graft-versus-host disease of gut after allogeneic hematopoietic 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 that does not improve within 5 days after 1-2 mg/kg of initial steroid therapy (steroid-refracotry) or that can hardly be reduced because of the exacerbation of gut aGVHD (steroid-dependent case). 3) Patients with coexisting non-GVHD enteropathy can also be enrolled when gut aGVHD is considered as a main cause of their symptoms. 4) 15 to 80 years of age at the time of consent. 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) Steroid sensitive aGVHD. 2) Progressive aGVHD, in which affected organ is irrelevant. 3) Uncontrollable infection. 4) Patients symptoms are considered to be caused mainly by enteropathy other than gut aGVHD. 5) PS 3 or higher. 6) Patients at high risk of aspiration. 7) Inadequate condition judged by primary physician.

Design outcomes

Primary

Measure	Time frame
Evaluation of adverse events that occurred or worsened within 1 week after FMT	—

Countries

Japan

Contacts

Public ContactTaro Tochigi

Hamanomachi hospital Department of hematology

tochigi-t@hamanomachi.jp+81927210831

Outcome results

None listed

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