Fecal Microbiota Transplantation in aGvHD After ASCT

Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: Graft Versus Host Disease in GI Tract
• Intervention / Treatment: Biological: Fecal microbiota transplantation

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Walter DDr. Spindelboeck; Phone Number: 0043 316 385 30195; Email: walter.spindelboeck@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz
      • Contact: Walter Spindelboeck, DDr.; Phone Number: 30195 0043316385; Email: walter.spindelboeck@medunigraz.at
      • Sub-Investigator: Walter Spindelboeck, DDr.
      • Principal Investigator: Peter Neumeister, Prof. Dr.
      • Principal Investigator: Christoph Högenauer, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Steroid refractory GI-aGvHD; Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids. Intervention: Fecal microbiota transplantation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GI-aGvHD remission	Sustained remission of GI-aGvHD (CR or PR)	90 days after first FMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GI-aGvHD remission	Sustained remission of GI-aGvHD (CR or PR)	45, 180 and 365 days after first FMT
Disease-free survival	GI-aGvHD free survival	180 and 365 days after first FMT
Recurrence of GI-GvHD	Recurrence of GI-GvHD	365 days after remission
Patient survival	Survival (death or alive)	180 and 365 days after first FMT
SUSAR (Suspected Unexpected Serious Adverse Reaction)	Number of lethal or non-lethal SUSAR's	within 48 hours after a FMT
SAE (Serious Adverse Event)	Number of lethal or non-lethal SAE's	within 48 hours after a FMT

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Peter Prof. Dr. Neumeister, Department of Internal Medicine, Division of Hematology, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Estimated): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Therapeutics; Biological Therapy; Fecal Microbiota Transplantation
• Other Study ID Numbers: GI-aGvHD_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No