Faecal microbiota transplantation for the prevention of GVHD after allogenic hematopoietic stem cell transplantation: a randomised, double-blind study

Grant received in 2026

DCCC has funded 200,000 DKK to the project.

Allogeneic haematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of malignanthaematological diseases. In Denmark, these transplantations are performed at Aarhus University Hospital and Rigshospitalet only, with approximately 160 patients per year. Graft-versus-host disease (GVHD) is a frequent and serious complication to allo-HSCT, which affects around 50% of the patients.

A growing body of evidence has highlighted the central role of the gut microbiota in outcomes after allo-HSCT. Faecal microbiota transplantation (FMT) is a treatment in which microorganisms from a healthy donor are transferred to the patient’s gut with the aim of restoring the gut microbiome. Preliminary observational studies and small pilot trials suggest that FMT may ameliorate established GVHD. However, it remains insufficiently explored whether early restoration of the gut microbiome after trabsplantaton can prevent the development of GVHD.

The study is planned as an investigator-initiated prospective, randomised, double-blind, placebo-controlled phase II clinical trial. The aim is to examine whether early restoration of a healthy gut microbiome after transplantation can reduce the risk of severe GVHD. The study will also investigate disease severity, infectious complications, mortality and non-relapse mortality, as well as symptoms and changes in the gut microbiome.

Funding from DCCC will support the development of the clinical protocol, preparation of regulatory approvals, collaboration agreements and grant applications, as well as meetings with project stakeholders.

Interdisciplinary organisation

The study is led by the Department of Haematology at Aarhus University Hospital and carried out in close collaboration with the Department of Hepatology and Gastroenterology, the Department of Clinical Immunology and Blood Bank, and the Centre for Faecal Microbiota Transplantation (CEFTA). The Department of Haematology at Rigshospitalet also participates in the study. The study is affiliated with the relevant DMCGs in haematology.