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Fecal Microbiota Transplantation in aGvHD After ASCT

Fecal Microbiota Transplantation in aGvHD After ASCT

Recruiting
18-70 years
All
Phase 3

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Overview

Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients.

Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum.

Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.

Eligibility

Inclusion Criteria:

  • first episode of histologically confirmed, steroid-refractory GI-aGvHD
  • reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement
  • eligibility for repeated colonoscopic procedures
  • informed consent

Exclusion Criteria:

  • complications during a previous colonoscopy
  • recurrent episode of GI-aGvHD
  • lacking cardiopulmonary fitness for repeated colonoscopic procedures
  • septic infection
  • acute extraintestinal organ failure (excluding bone marrow)
  • mechanical ileus

Study details
    Graft Versus Host Disease in GI Tract

NCT03819803

Medical University of Graz

22 March 2024

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