FMT for Pediatric SR-aGVHD

This is a pilot, prospective, non-profit, multicenter, uncontrolled, open-label study to evaluate the safety and feasibility of FMT in patients aged between 3 months and 25 years suffering from acute intestinal GVHD resistant to conventional steroid therapy. Eligible patients will receive 1-3 FMT via naso-jejunal tube or endoscopy.

NCT Number	NCT07602751
Lead Sponsor	Bambino Gesù Hospital and Research Institute Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna, University Hospital, Padua, Italy
Conditions	Acute Graft Versus Host Disease in Intestine
Enrollment	20 participants
Start Date	2026-05-18
Primary Completion	2028-06 (estimated)
Study Completion	2029-05 (estimated)
Updated on ClinicalTrials.gov	2026-05-22