Safety and efficacy of fecal microbiota transplantation for steroid resistant acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation

Safety and efficacy of fecal microbiota transplantation for steroid resistant acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation - Safety and efficacy of FMT for acute GVHD of gut in alloHSCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015115

Enrollment

Registered

2015-06-11

Start date

2014-08-01

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 acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation

Interventions

FMT, start as soon as possible after meeting inclusion criteria, up to 2 cycles.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Acute GVHD of gut 2) GVHD which does not improve despite adequate dose (1mg/kg/day or more of PSL) of steroid, or steroid dose is difficult to reduce because of exacerbation of GVHD. 3)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Steroid sensitive GVHD 2)Progressive GVHD despite steroid therapy (1mg/kg/day or more of PSL) 4)Diarrhea due to other cause 5)Inadequate condition as considered by primary physician

Design outcomes

Primary

Measure	Time frame
Safety of fecal microbiota transplantation (FMT)	—

Secondary

Measure	Time frame
Efficacy for acute GVHD of gut Efficacy for acute GVHD of skin or liver Incidence of clostridium difficile infection	—

Countries

Japan

Contacts

Public ContactKazuhiko Kakihana

Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital Hematology division

kakihana@cick.jp03-3823-2101

Outcome results

None listed

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