Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD
Recruiting
Phase 2
Interventional Study
Graft vs Host Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 35 (estimated)
- Sponsor
- Chang Gung Memorial Hospital · Other
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About This Trial
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment for various hematologic diseases. However, one of the major challenges of allo-HSCT is the occurrence of graft-versus-host disease (GvHD), particularly acute gastrointestinal GvHD (GI-GvHD). GvHD occurs when donor T cells recognize the recipient's tissue as foreign and mount an immune attack against it. Acute …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Stage II to IV steroid refractory acute GI-GvHD in allo-HSCT recipients
1. Stage II to IV acute GI-GVHD subjects, having \>1000 mL stool per day, diarrhea \> 5 times/day, or abdominal cramping, bleeding or ileus, AND
2. Resistant to a first-line therapy with corticoste…
Contacts