Fecal Microbiota Transplantation in aGvHD After ASCT

NCT03819803 | Recruiting Phase 3

• 1 other identifier: GI-aGvHD_01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• GI-aGvHD remission

  Sustained remission of GI-aGvHD (CR or PR)

  90 days after first FMT

Secondary Outcomes (6)

• GI-aGvHD remission

  45, 180 and 365 days after first FMT

• Disease-free survival

  180 and 365 days after first FMT

• Recurrence of GI-GvHD

  365 days after remission

• Patient survival

  180 and 365 days after first FMT

• SUSAR (Suspected Unexpected Serious Adverse Reaction)

  within 48 hours after a FMT

Study Arms (1)

Steroid refractory GI-aGvHD

EXPERIMENTAL

Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids. Intervention: Fecal microbiota transplantation

Biological: Fecal microbiota transplantation

Interventions

Fecal microbiota transplantation BIOLOGICAL

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

Steroid refractory GI-aGvHD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

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

Graz, Styria, 8036, Austria

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Peter Prof. Dr. Neumeister

  Department of Internal Medicine, Division of Hematology, Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter DDr. Spindelboeck

CONTACT

0043 316 385 30195; walter.spindelboeck@medunigraz.at

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: January 29, 2019
• Study Start: March 1, 2017
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)