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the EXPOSITION Study

NCT06325358 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-03-22

No results posted yet for this study

Summary

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
  • Environmental Exposure
  • Lifestyle Factors

Sponsors & Collaborators

  • National Research Council (Consiglio Nazionale delle Ricerche)

    collaborator UNKNOWN

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    collaborator OTHER

  • University of Pavia

    lead OTHER

Principal Investigators

  • Eleonora Tavazzi · Neurological Institute-Foundation IRCCS Casimiro Mondino, Pavia, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06325358 on ClinicalTrials.gov