Fecal microbiota transplant in chronic fatigue

Project description

This project aims to determine if there is a true cause and effect relationship between a dysbiotic gut flora and ME/CFS by testing if treatment of the observed dysbiosis by fecal microbiota transplantation (FMT) can resolve ME/CFS symptoms. In this process, collection of blood, fecal, and urine samples before and after FMT will open the possibility to explore the relationship between the gut flora, immune response, host energy metabolism and ME/CFS using technologies of microbiomics, metabolomics and immunological characterizations for a better understanding of the pathobiology of the disease.

This is a single-center stratified (on gender and donor), block randomised, placebo-controlled, parallel group trial with 12-months follow-up of 80 ME/CFS patients. Participants will be randomised to treatment by preprocessed thawed donor fecal microbiota transplant or preprocessed thawed autologous fecal microbiota transplant. The primary endpoint is the efficacy of FMT at three months by the Fatigue Severity Scale. The investigators will use patient reported outcomes for primary and secondary outcome measures.

Previous studies suggest that a dysbiosis of the gut microbiota may be a key feature in ME/CFS. The investigators hypothesise that:

1) ME/CFS is caused by a dysbiosis in the gut flora causing barrier leakage of bacterial products, a low grade systemic immune activation and disturbances in the host energy metabolism.

2) Recovery of a normal gut flora by FMT alleviates symptoms and may even induce remission of ME/CFS.

Description adapted from cinical trial website: see link above.