protocolSection identificationModule nctId: NCT06325358, orgStudyIdInfo id: 0040083/23, briefTitle: the EXPOSITION Study, acronym: EXPOSITION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, collaborators name: National Research Council (Consiglio Nazionale delle Ricerche), collaborators name: IRCCS National Neurological Institute "C. Mondino" Foundation, descriptionModule 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., conditionsModule conditions: Multiple Sclerosis, Relapsing-Remitting, conditions: Environmental Exposure, conditions: Lifestyle Factors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: microRNAs, primaryOutcomes measure: Air quality, primaryOutcomes measure: Nutritional assessment, primaryOutcomes measure: Neurofilament (NfL), primaryOutcomes measure: Cytokines, primaryOutcomes measure: the Body Mass Index (BMI), primaryOutcomes measure: Physical activity, primaryOutcomes measure: Quality of life related to MS, primaryOutcomes measure: Sleep Quality, primaryOutcomes measure: Smoking habits, primaryOutcomes measure: Dietary supplements use, primaryOutcomes measure: Adherence to Mediterranean diet, primaryOutcomes measure: Effect of diet on inflammation, primaryOutcomes measure: waist and height ratio (WHtR), primaryOutcomes measure: Bioelectrical impedance, secondaryOutcomes measure: Microbiome and biological biomarkers of oxidative stress and inflammation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Foundation C. Mondino, city: Pavia, zip: 27100, country: Italy, contacts name: Eleonora Tavazzi, role: CONTACT, phone: 0382 380403, phoneExt: +39, email: eleonora.tavazzi@mondino.it, contacts name: Roberto Bergamaschi, role: SUB_INVESTIGATOR, contacts name: Eleonora Tavazzi, role: PRINCIPAL_INVESTIGATOR, contacts name: Hellas Cena, role: SUB_INVESTIGATOR, contacts name: Rachele de Giuseppe, role: SUB_INVESTIGATOR, contacts name: Beatrice Maccarini, role: SUB_INVESTIGATOR, contacts name: Aliki Kalmpourtzidou, role: SUB_INVESTIGATOR, contacts name: Elena Colombo, role: SUB_INVESTIGATOR, contacts name: Eleonora Rigoni, role: SUB_INVESTIGATOR, contacts name: Lara Ahmad, role: SUB_INVESTIGATOR, contacts name: Monica Bianchi, role: SUB_INVESTIGATOR, contacts name: Veronica Tosca, role: SUB_INVESTIGATOR, contacts name: Luciana Gracardi, role: SUB_INVESTIGATOR, contacts name: Romina Sarchi, role: SUB_INVESTIGATOR, contacts name: Anna Scarabotto, role: SUB_INVESTIGATOR, contacts name: Matteo Gastaldi, role: SUB_INVESTIGATOR, contacts name: Ghanya Al-Naqeb, role: SUB_INVESTIGATOR, contacts name: Federica Loperfido, role: SUB_INVESTIGATOR, contacts name: Mulubirhan A. Alemayohu, role: SUB_INVESTIGATOR, contacts name: Maria Cristina Monti, role: SUB_INVESTIGATOR, contacts name: Cristina Montomoli, role: SUB_INVESTIGATOR, contacts name: Danilo Porro, role: SUB_INVESTIGATOR, contacts name: Gloria Bertoli, role: SUB_INVESTIGATOR, contacts name: Alessia Lo Dico, role: SUB_INVESTIGATOR, contacts name: Clarissa Consolandi, role: SUB_INVESTIGATOR, contacts name: Marco Severgnini, role: SUB_INVESTIGATOR, contacts name: Francesca Costabile, role: SUB_INVESTIGATOR, contacts name: Stefano Decesari, role: SUB_INVESTIGATOR, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False