the EXPOSITION Study

University of Pavia

Status: Not yet enrolling

Conditions: Environmental Exposure; Multiple Sclerosis, Relapsing-Remitting; Lifestyle Factors

Study type: Observational

Funder types: Other

Identifiers

NCT06325358

0040083/23

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• We will include persons with Multiple Sclerosis (pwMS) attending the Centro Sclerosi Multipla of the IRCCS Fondazione C. Mondino of Pavia, according to the following inclusion criteria:

  • Age ≥ 18 years
  • Diagnosis of MS according to 2017 McDonald criteria
  • Relapsing-remitting course (RR)
  • Routine clinical examinations scheduled in the study period September 15, 2023, to March 15, 2024,
  • Residing in the provinces of Pavia and Milano
  • Informed consent form signed

Exclusion criteria

• Exclusion criteria will involve people refusing to participate in the study or people not completely meet the inclusion criteria. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled.

Trial design

200 participants in 1 patient group

Subjects with Multiple sclerosis

Description:

Age ≥ 18 years * Diagnosis of MS according to 2017 McDonald criteria * Relapsing-remitting (RR) MS * Residence in the provinces of Pavia or Milan (Italy) * Informed consent form signed