Study design
STERILE
We set up a prospective, double-blinded, randomised, placebo-controlled intervention study that was performed in our academic hospital, the Amsterdam University Medical Centres location AMC in the Netherlands. After passing screening, 24 subjects with MetSyn were randomised to receive a sterile FFT from a lean healthy donor or a placebo transplant. Prior to the intervention and after 28 days at follow-up, subjects underwent an OGTT to assess their glucose metabolism. In addition, a week prior to one week after intervention, subjects monitored their blood glucose using a flash glucose monitoring device (Freestyle Libre). Faecal samples were collected at multiple timepoints between baseline and follow-up to study dynamic changes in the microbiome. Finally, during every study visit a medical exam was conducted in addition to blood plasma collection to assess the safety of the intervention. Figure 