nctId: NCT06325358 id: 0040083/23 briefTitle: the EXPOSITION Study acronym: EXPOSITION overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-30 date: 2024-12-30 date: 2024-03-22 date: 2024-03-22 name: University of Pavia class: OTHER name: National Research Council (Consiglio Nazionale delle Ricerche) name: IRCCS National Neurological Institute "C. Mondino" Foundation briefSummary: This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage. conditions: Multiple Sclerosis, Relapsing-Remitting conditions: Environmental Exposure conditions: Lifestyle Factors studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: microRNAs measure: Air quality measure: Nutritional assessment measure: Neurofilament (NfL) measure: Cytokines measure: the Body Mass Index (BMI) measure: Physical activity measure: Quality of life related to MS measure: Sleep Quality measure: Smoking habits measure: Dietary supplements use measure: Adherence to Mediterranean diet measure: Effect of diet on inflammation measure: waist and height ratio (WHtR) measure: Bioelectrical impedance measure: Microbiome and biological biomarkers of oxidative stress and inflammation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Foundation C. Mondino city: Pavia zip: 27100 country: Italy name: Eleonora Tavazzi role: CONTACT phone: 0382 380403 phoneExt: +39 email: eleonora.tavazzi@mondino.it name: Roberto Bergamaschi role: SUB_INVESTIGATOR name: Eleonora Tavazzi role: PRINCIPAL_INVESTIGATOR name: Hellas Cena role: SUB_INVESTIGATOR name: Rachele de Giuseppe role: SUB_INVESTIGATOR name: Beatrice Maccarini role: SUB_INVESTIGATOR name: Aliki Kalmpourtzidou role: SUB_INVESTIGATOR name: Elena Colombo role: SUB_INVESTIGATOR name: Eleonora Rigoni role: SUB_INVESTIGATOR name: Lara Ahmad role: SUB_INVESTIGATOR name: Monica Bianchi role: SUB_INVESTIGATOR name: Veronica Tosca role: SUB_INVESTIGATOR name: Luciana Gracardi role: SUB_INVESTIGATOR name: Romina Sarchi role: SUB_INVESTIGATOR name: Anna Scarabotto role: SUB_INVESTIGATOR name: Matteo Gastaldi role: SUB_INVESTIGATOR name: Ghanya Al-Naqeb role: SUB_INVESTIGATOR name: Federica Loperfido role: SUB_INVESTIGATOR name: Mulubirhan A. Alemayohu role: SUB_INVESTIGATOR name: Maria Cristina Monti role: SUB_INVESTIGATOR name: Cristina Montomoli role: SUB_INVESTIGATOR name: Danilo Porro role: SUB_INVESTIGATOR name: Gloria Bertoli role: SUB_INVESTIGATOR name: Alessia Lo Dico role: SUB_INVESTIGATOR name: Clarissa Consolandi role: SUB_INVESTIGATOR name: Marco Severgnini role: SUB_INVESTIGATOR name: Francesca Costabile role: SUB_INVESTIGATOR name: Stefano Decesari role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False