FMT for Pediatric SR-aGVHD

Fecal Microbiota Transplantation for the Treatment of Steroid-refractory Graft-versus-host Disease.

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.

Inclusion Criteria:

• Diagnosis of hematological disease, malignant or non-malignant;
• Patients undergoing allogeneic stem cell transplantation from a familial or unrelated donor;
• Presence of acute GVHD with intestinal involvement (grade II-IV), steroid-resistant (i.e., with progression after 3 days of high-dose steroid therapy (methylprednisolone > 2 mg/kg), no response after 7 days, progression during steroid tapering, or failure to achieve remission on day 28 from the start of steroid therapy), for those who have no indication for other second- or third-line therapies;
• Signed informed consent.

Exclusion Criteria:

• Presence of concurrent bacterial infections requiring systemic antibiotic therapy;
• Positivity for anti-HIV or anti-HCV antibodies, or for HbsAg with HBV-DNA positive by PCR;
• Presence of severe mucositis;
• History of chronic inflammatory bowel disease.