FMT for Pediatric SR-aGVHD
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3-25
SponsorBambino Gesù Hospital and Research Institute
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Fecal Microbial Transplantation
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Bambino Gesù Hospital and Research Institute
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
University Hospital, Padua, Italy
Collaborator
Source ClinicalTrials.gov