Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT03819803

Fecal Microbiota Transplantation in aGvHD After ASCT

Led by Medical University of Graz · Updated on 2025-12-02

15

Participants Needed

1

Research Sites

513 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Fecal Microbiota Transplantation in aGvHD After ASCT

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • First episode of histologically confirmed, steroid-refractory gastrointestinal acute graft-versus-host disease (GI-aGvHD)
  • Reduced bacterial diversity in the patient's stool microbiota confirmed by 16s-rDNA measurement
  • Eligible for repeated colonoscopic procedures
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Complications during a previous colonoscopy
  • Recurrent episode of gastrointestinal acute graft-versus-host disease (GI-aGvHD)
  • Lack of cardiopulmonary fitness for repeated colonoscopic procedures
  • Presence of septic infection
  • Acute extraintestinal organ failure (excluding bone marrow)
  • Mechanical ileus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz

Graz, Styria, Austria, 8036

Actively Recruiting

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Research Team

W

Walter DDr. Spindelboeck

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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