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FMT for Pediatric SR-aGVHD

RecruitingPhase 1, Phase 2Ages 3 Months - 25 YearsAllBambino Gesù Hospital and Research Institute
NCT07602751 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Fecal Microbial Transplantation
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Where

3 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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