NCT07602751Not yet recruitingPhase 1
Fecal Microbiota Transplantation for the Treatment of Steroid-refractory Graft-versus-host Disease.
Bambino Gesù Hospital and Research Institute3 sites in 1 country20 target enrollmentStarted: May 18, 2026Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 3
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Months to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Study Sites (3)
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