Fecal Microbiota Transplantation in aGvHD After ASCT

NCT ID: NCT03819803

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Steroid refractory GI-aGvHD

Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids.

Intervention: Fecal microbiota transplantation

Group Type: EXPERIMENTAL

Fecal microbiota transplantation

Intervention Type: BIOLOGICAL

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

Interventions

Fecal microbiota transplantation

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Prof. Dr. Neumeister

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Graz, Styria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Walter DDr. Spindelboeck

Role: CONTACT

walter.spindelboeck@medunigraz.at

0043 316 385 30195

Facility Contacts

Walter Spindelboeck, DDr.

Role: primary

walter.spindelboeck@medunigraz.at

0043316385 ext. 30195

Other Identifiers

GI-aGvHD_01

Identifier Type: -

Identifier Source: org_study_id