NCT03819803

Fecal Microbiota Transplantation in aGvHD After ASCT

Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients. Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum. Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.

Conditions

• Graft Versus Host Disease in GI Tract

Interventions

Type	Name	Description
BIOLOGICAL	Fecal microbiota transplantation	200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum

Timeline

• Start date: 2017-03-01
• Primary completion: 2026-03-01
• Completion: 2026-12-31
• First posted: 2019-01-29
• Last updated: 2025-12-02

Locations

1 site across 1 country: Austria