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Fecal Microbiota Transplantation in aGvHD After ASCT

NCT03819803 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-02

No results posted yet for this study

Summary

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.

Conditions

  • Graft Versus Host Disease in GI Tract

Interventions

BIOLOGICAL

Fecal microbiota transplantation

200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Peter Prof. Dr. Neumeister · Department of Internal Medicine, Division of Hematology, Medical University of Graz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2026-03-01
Completion
2026-12-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03819803 on ClinicalTrials.gov