Fecal microbiota transplant in chronic fatigue syndrome - an RCT The comeback study

In a single center, double blinded, placebo-controlled, parallel group study with 12-month follow-up at the University Hospital of North Norway in the city of Harstad we will perform the first RCT in treating chronic fatigue syndrome/myalgic encephalopathy (CFS/ME) by fecal microbiota transplantation. This project aims to determine if there is a true cause and effect relationship between a dysbiotic gut flora and CFS/ME by testing if treatment of the observed dysbiosis by fecal microbiota transplantation (FMT) also can resolve CFS/ME 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 CFS/ME using technologies of microbiomics, metabolomics and immunological characterizations for a better understanding of the pathobiology of CFS/ME. The extensive microbiological, immunological and metabolomic characterization also opens the opportunity to identify novel biomarkers for CFS/ME and may provide causal insights in the relationship between the gut microbiome and host energy metabolism.

-

This study implements a treatment that has been suggested for CFS/ME based on a poor quality open label study that showed persistent relief after transplantation of enteric bacteria. Theoretical framework is based on characterization studies in CFS/ME patients vs controls where gut bacteria and biomarkers for immune activation and leaky gut differs. Current knowledge is expanded by determining if there is a true cause and effect relationship between a dysbiotic gut flora and CFS/ME By fecal microbiota transplantation (FMT) we will establish a healthy gut flora, hypothesizing this will give symptom relief Establishing of a healthy gut flora by FMT is well documented by research in clostridium difficile colitis. Mode of delivery for FMT is easy, cheap and not limited to secondary care. If effective, treatment can be made available to a patient group suffering a disease with high impact on the individual and society by the nature of the severity This is a single center, double blinded, placebo-controlled, parallel group study with 12-month follow-up conducted at the University Hospital of North Norway, Harstad. Caregivers in the primary- and secondary healthcare recruit participants. Inclusion is based on the Canadian Criteria. 78 CSF/ME participants are allocated to receive a donor transplant or a placebo transplantation of their own feces Self assessment questionnaires and biodata for the technologies of microbiomics, metabolomics and immunological characterizations will be collected before intervention and in the 12 months follow up. This may lead to the discovery of biomarkers and a better understanding of the pathophysiology of CFS/ME Primary endpoint; Improvement in the Chalder Fatigue Scale at 3 month. A problem is the lack of consensus on symptom severity assessment. Also the logistics in the trial are challenging. We will overcome the difficulties by our personal experience in FMT trials and guidance by users that understands challenges with CFS/ME