This has led to the development of new research projects relating to the gut-microbiome-brain axis and understanding how the intestinal microbiome impacts on mental health and the development of neurodegenerative diseases, and the intestinal virome and the role that prokaryotic and eukaryotic viruses play in microbial homeostasis and dysbiosis. Abstract: Abstract not available at time of printing. Dr Peter Johnsen University Hospital of North Norway, Harstad, Norway - Internal Medicine Dr Johnsen works in the medical department at the University of Northern Norway in Harstad. He is currently involved in the clinical trial of FMT which is being funded by the Norwegian Health Council. Five million Norwegian kroner has been awarded for the trial. Together, it will include 80 participants who either receive treatment with FMT from a healthy donor or placebo. The study is double blinded, which means that neither participants nor scientists will know who received the treatment from donor or placebo before the study ends. Startup with the inclusion of participants begins during Summer 2018. Abstract: The Comeback study – a double blinded randomized placebo-controlled trial testing the efficacy of faecal microbiota transplantation (FMT) in CFS/ME Earlier published data suggests that a dysbiotic gut flora may be an important factor in the pathophysiology of CFS/ME. Differences in host metabolism and immune activation pointing to a leaky gut are found in the context of at gut flora that is less diverse with an altered composition when CFS/ME is compared to healthy controls. In addition, an open label study has shown persistent relief in CFS/ME after transplantation of enteric bacteria. To test the gut dysbiosis hypothesis in CFS/ME we will launch a double blind randomized, placebo-controlled, parallel-group, single-centre trial to test FMT as treatment for CFS/ME. Eighty CFS/ME participants will receive either donor transplant or placebo FMT, with 12 months follow up period. Primary endpoint is the efficacy of FMT at three months. We will use a patient reported outcome by the Chalder Fatigue Scale to determine efficacy. Recently we performed a trial with the same study design testing the effect of FMT in irritable bowel syndrome (IBS). In the primary endpoint three months after treatment there was significant improvement on gastrointestinal complaints. Preliminary results also show a significant effect on fatigue, which is a common complaint in irritable bowel syndrome. Conversely, gastrointestinal complaints are common in CFS/ME. Because of our previous experience with FMT for functional disease, the symptom overlap between IBS and CFS/ME, and the evidence for an involvement of the gut microbiome in both, we are eager to lunch our trial in August 2018. We expect to have the final results ready by August 2020. UK charity Invest in ME Research has provided us with a network of great collaborators that may help us to establish a true cause and effect relationship by performing analysis of immunological markers and the gut metagenome. Biobanking of feces, blood and urine is an important asset to this study and will allow for tandem characterization of the immune response, metabolome and metagenome in CFS/ME. In outlining the study protocol we found the lack of consensus on symptom severity assessment challenging. We are hoping for input on how we can optimize the use of our biobank for insights in CFS/ME pathophysiology and discussions on what are the most relevant endpoints in efficacy studies for CFS/ME. We are thankful for the possibility the Invest in ME Research Foundation has given us to meet and network with the world leading expertise on CFS/ME. There is great interest in and a commercialisation of FMT treatment, including FMT for CFS/ME. However, this enthusiasm needs to be balanced with a need for caution with the use of FMT. The screening regime for FMT donors is just as extensive as the regime for donors of blood, cells and live tissue. Our main aim is to provide physicians and other caregivers to CFS/ME patients’ evidence-based advice regarding the efficacy of FMT. Thereby, this study will fulfil its intention regardless of the conclusion. However, there is a greater potential in this trial. Participants may serve as their own control pinpointing which mechanisms change if they transcend from sick to healthy or improved. In conjunction with the intervention any hypothesis can be tested in silico against the clinical outcomes to identify new therapeutic targets and biomarkers for improving diagnosis or personalizing FMT treatment. Invest in ME research (Charity Nr. 1153730) www.investinme.org Page 47 of 56
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