In the past 24 months, we set up the Women4Health cohort (www.women4health.it) central to the SEMICYCLE project. Finding potential volunteers who met the required enrolment criteria and were willing to dedicate to the study observation period, was a challenging task. We initially set up the first recruitment center in Trieste (IRCCS Burlo Garofolo, Italy), and recently two additional centers have joined: the University Medical center in Cagliari (AOU Cagliari, Italy), and the University Medical Center in Bologna (IRCCS Policlinico San'Orsola, Bologna, Italy). Recruitment is still ongoing.
While the data is collected, we start processing data and biological samples as they came in. This allowed us to set up all protocols for the lab and to develop the bioinformatic and statistical workflow. In particular, the development of the bioinformatic and statistical analyses for handling longitudinal data and for the identification of causal relationship is an important achievement since no other pipelines were available in our group and this is yet uncommon on the scientific field.
Using the preliminary data collected, we characterized both the gut and vaginal microbiomes, as well as proteomic data, along with sex hormones, cardiometabolic blood biomarkers and questionnaire-derived data and evaluated longitudinal changes and causal relationships. We identified several variables for all data type (microbiome, blood traits, proteomics) that significantly change during the menstrual cycles, along the sex-hormones. We also identified several interesting causal relationships. We expect the recruitment of volunteers to be completed by next year and we will extend the analyses to the largest set of data to confirm their robustness. Join effort with our collaborators will then be pivotal to evaluate replication of the findings in other cohorts, and to exploit their impact on cardiometabolic diseases.
