Clinical trial NCT06325358: the EXPOSITION Study
Official title: EXPOSITION (EXPosome, Oxidative Stress and InflammaTION) in Persons With Multiple Sclerosis Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis, Relapsing-Remitting
Environmental Exposure
Lifestyle Factors
Keywords: multiple sclerosis
exposome
microRNA
cytokines
microbiome
neurofilament
air pollution
urbanization
lifestyle
nutrition
physical activity
inflammation
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: National Research Council (Consiglio Nazionale delle Ricerche)
name: IRCCS National Neurological Institute "C. Mondino" Foundation
First posted: 2024-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with Multiple Sclerosis (pwMS) attending the Centro Sclerosi Multipla of the IRCCS Fondazione C. Mondino of Pavia will be eligible, 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

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: microRNAs
timeFrame: from March 2024 to July 2024 visit
measure: Air quality
timeFrame: from March 2023 to July 2023
measure: Nutritional assessment
timeFrame: from March 2024 to July 2024
measure: Neurofilament (NfL)
timeFrame: from March 2024 to July 2024
measure: Cytokines
timeFrame: from March 2024 to July 2024
measure: the Body Mass Index (BMI)
timeFrame: from March 2024 to July 2024
measure: Physical activity
timeFrame: from March 2024 to July 2024
measure: Quality of life related to MS
timeFrame: from March 2024 to July 2024
measure: Sleep Quality
timeFrame: from March 2024 to July 2024
measure: Smoking habits
timeFrame: from March 2024 to July 2024
measure: Dietary supplements use
timeFrame: from March 2024 to July 2024
measure: Adherence to Mediterranean diet
timeFrame: from March 2024 to July 2024
measure: Effect of diet on inflammation
timeFrame: from March 2024 to July 2024
measure: waist and height ratio (WHtR)
timeFrame: from March 2024 to July 2024
measure: Bioelectrical impedance
timeFrame: from March 2024 to July 2024
Secondary outcomes:
measure: Microbiome and biological biomarkers of oxidative stress and inflammation
timeFrame: from March 2024 to July 2024
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Foundation C. Mondino
Study officials:
affiliation: Neurological Institute-Foundation IRCCS Casimiro Mondino, Pavia, Italy
name: Eleonora Tavazzi
role: PRINCIPAL_INVESTIGATOR
References: