RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

FMT for Pediatric SR-aGVHD

Sponsor: Bambino Gesù Hospital and Research Institute • ClinicalTrials.gov ID: NCT07602751

Registry updated: 2026-10-20

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Description

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.

Interventions

Fecal Microbial Transplantation (Biological)
The administration of the fecal preparation (from a related donor or a third party donor) will be carried out via esophagogastroduodenoscopy, with the release of the fecal preparation into the duodenum; or via a nasoduodenal tube, with the release of the fecal preparation into the duodenum at a 'dose' of 7-12 ml/kg, up to a maximum of 250 ml/administration; or via colonoscopy. In the latter case, mucosal biopsies will not be performed to reduce the risk of bacterial translocation. In some subjects, the possibility of administering the emulsion via ENEMA will be evaluated. Cases will be selected based on specific clinical indications. In the case of a partial response, after evaluating the risk/benefit ratio, a second infusion can be performed after 3 days. The procedure can be repeated a third time later (7 days) in case of a new flare of intestinal GVHD after initial improvement.

Eligibility criteria

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.

Conditions

Acute Graft Versus Host Disease in Intestine

Locations

Pediatric Hematology and Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy
UOC Clinica di Oncoematologia Pediatrica, Azienda Ospedale-Università Padova — Padova, Italy
Department of Hematology/Oncology, Cell and Gene Therapy, IRCCS Bambino Gesù Children's Hospital — Roma, Italy

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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