Multiple Sclerosis, Relapsing-RemittingEXPOSITIONNCT06325358
the EXPOSITION Study
An observational study of Multiple Sclerosis, Relapsing-Remitting and Environmental Exposure, run by University of Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Environmental Exposure, Lifestyle Factors
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Foundation C. Mondino
Pavia, 27100
Eleonora Tavazzi, 0382 380403 ext. +39, eleonora.tavazzi@mondino.it
Roberto Bergamaschi
About this study
Official title: EXPOSITION (EXPosome, Oxidative Stress and InflammaTION) in Persons With Multiple Sclerosis Study
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.
- Keywords
- multiple sclerosis, exposome, microRNA, cytokines, microbiome, neurofilament, air pollution, urbanization, lifestyle, nutrition, physical activity, inflammation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Multiple sclerosis | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNAs
The differential expression of a set of 7 specific circulating plasma microRNAs from the blood of each pwMS will be measured. The set of miRNAs has been already selected based on their significant deregulated expression in MS, as evidenced in a bioinformatic analysis conducted using computational resources. A portion of serum samples will be collected and immediately frozen at -20°C. After being transported, serum samples will be thawed and the circulating RNAs will be extracted. After a step of microRNA specific reverse transcription, the copy-DNA obtained will be used as the template for Real Time-qPCR analyses of selected miRNAs by Singleplex TaqMan microRNA assay reactions.The method of Livak et al. will be applied for the comparative analysis of the relative expression of the selected microRNAs in serum samples, considering different combinations of the external exposome variables.
Measured: from March 2024 to July 2024 visit
Air quality
Spatial information on pollutants such as PM10, PM2.5, PM1.0 expressed in microg/m3, nanoparticulate (n/cm3), and black carbon (microg/m3) from CAMS and CHIMBO databases and from Sentinel-5P TROPOMI will be included as gridded emissions in 0.1° x 0.1° (long-lat) resolution for the whole time series (daily values), from March 2023 onwards from the Pavia and Milano provinces. Large Eddy Simulations will be carried out over such areas with a high spatial-temporal resolution for estimating - in a quantitative manner - the 3D pollutants concentration at the street level.The grid will be further subdivided into the municipalities of the two provinces and a "personal exposure" will be also assessed, based on the geographic position of each pwMS derived from the residence address (geo-positioning).
Measured: from March 2023 to July 2023
Nutritional assessment
The dietary habits of the participants will be evaluated with the use of a validated food frequency questionnaire (FFQ) adapted to the Italian population and adjusted based on current food trends, such as the consumption of plant-based milk and meat. Detailed information about the daily food consumption of pwMS will be gained through a 24-h dietary recall.
Measured: from March 2024 to July 2024
Neurofilament (NfL)
Human NfL will be assessed on plasma samples by Simple Plex assay (ProteinSimple, CA, USA) on Ella device (ProteinSimple, CA, USA), according to the manufacturer's instructions. Calibration of Ella will be performed using the incartridge factory standard curve, and plasma samples will be measured with a 1:2 dilution in Sample Diluent (ProteinSimple, CA, USA). A single well was used for each sample as triplicates assays are automatically performed in Simple Plex assay microfluidic platform. The LLOQ is 2.70 pg/ml; the upper limit of quantification is 10,290.00 pg/ml.
Measured: from March 2024 to July 2024
Cytokines
Serum levels of IL1-beta, IL2, IL4, IL6, IL-10, IL12, IL17, IL22, IL23, TGF-beta, GM-CSF, TNF-alpha, IFN-gamma expressed in pg/mL will be assessed by using CXCL10 (performed using Simple Plex , R\&D and commercial ELISA kit).
Measured: from March 2024 to July 2024
the Body Mass Index (BMI)
Weight in kg and height in m will be measured in order to calculate the Body Mass Index (BMI) as the ratio of weight (kg) to height (m) squared.
Measured: from March 2024 to July 2024
Physical activity
Physical activity levels will be evaluated by using the International Physical Activity Questionnaires (IPAQ) . The questionnaire is composed of 7 questions concerning the last 7 days levels of moderate, vigorous and sedentary physical activity. The metabolic equivalent of tasks (MET) will be calculated using the frequency and duration of physical activity and will be reported as MET-min/wk.
Measured: from March 2024 to July 2024
Quality of life related to MS
Quality of life will be evaluated by Multiple Sclerosis Quality of Life-29 (MSQOL-29), a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.
Measured: from March 2024 to July 2024
Sleep Quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire. The questionnaire consists of 9 multiple-choice items divided into 5 different components related to subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction. The global PSQI score will be obtained by considering the scores of all the components and it ranges from 0 to 13. The PSQI cut-off of 5 or above indicates poor sleep quality.
Measured: from March 2024 to July 2024
Smoking habits
Cigarette smoking habits will be registered considering patients who are smoking, never smoked and quit smoking. The number of cigarettes smoked per day and the years of smoking will be recorded for smokers. Ex-smokers will be asked the number of years not smoking, the number of years that have smoked and the number of cigarettes smoked per day during their smoking years.
Measured: from March 2024 to July 2024
Dietary supplements use
Dietary supplements use will be assessed based on the type and nutrients included in the dietary supplements, their dose and their frequency of use.
Measured: from March 2024 to July 2024
Adherence to Mediterranean diet
Adherence to the Mediterranean dietary model will be assessed by applying the MEDI-LITE score. The MEDI-LITE score is based on a questionnaire, which investigates the frequency of consumption of nine classes of food. The final score varies from 0 (low adherence) to 18 (high adherence). Overall, subjects who will obtain a score higher than 9 will have a significantly increased adherence to the Mediterranean Diet.
Measured: from March 2024 to July 2024
Effect of diet on inflammation
The Dietary Inflammatory Index (DII) will be also calculated to quantify the overall effect of diet on inflammatory potential. The DII will be calculated based on the daily food consumption and then based on it the food parameters included in DII will be evaluated, such as vitamins, macronutrients, minerals, green/black tea and others.
Measured: from March 2024 to July 2024
waist and height ratio (WHtR)
The waist circumference and (cm) height (cm) will be measured in order to calculate their ratio (WHtR), a good predictor of abdominal adiposity in adults, will be also calculated.
Measured: from March 2024 to July 2024
Bioelectrical impedance
Bioelectrical impedance analysis will be used for the analysis of phase angle (PhA), which is considered an indicator of cellular health and malnutrition.
Measured: from March 2024 to July 2024
Secondary outcomes (1)
Microbiome and biological biomarkers of oxidative stress and inflammation
The percentage of each bacterial operational taxonomic units (OTUs) was investigated separately for each sample, providing relative abundance data among the samples based on the the relative numbers of reads within each.
Microbial profiles will be evaluated in terms of
- Biodiversity (alpha-diversity), estimating the number of taxa in each sample and statistically comparing estimates across the experimental groups;
- Composition (beta-diversity), evaluating the pairwise similarity among the samples and clustering them according to their distances;
- Bacterial groups (relative abundances), evaluating whether a bacterial taxon is significantly increased or depleted in pwMS belonging to the different exposome variables under investigation.
Measured: from March 2024 to July 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start15 Apr 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council (Consiglio Nazionale delle Ricerche), IRCCS National Neurological Institute "C. Mondino" Foundation
- Responsible party
- Sponsor
- Investigators
- Eleonora Tavazzi, Principal investigator, Neurological Institute-Foundation IRCCS Casimiro Mondino, Pavia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325358
- Sponsor's protocol ID
- 0040083/23
- Acronym
- EXPOSITION
- Status last verified
- Oct 2023
- First submitted
- 9 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Monti MC, De Giuseppe R, Bertoli G, Alemayohu MA, Al-Naqeb G, Ballante E, Bergamaschi R, Camboni T, Ceccarani C, Ceriani C, Colombo E, Consolandi C, Costabile F, Decesari S, Gallivanone F, Galuzzi BG, Gastaldi M, Gervasoni C, Gugiatti S, Itri T, Kalmpourtzidou A, Landi TC, Lanzotti A, Dico AL, Loperfido F, Maccarini B, Mazza A, Montomoli C, Oddone E, Paulin N, Pellizzer C, Pernetti R, Scarabotto A, Sellaro F, Severgnini M, Summa D, Vivone G, Porro D, Cena H, Tavazzi E. Exposome, oxidative stress and inflammation in persons with multiple sclerosis: the EXPOSITION study protocol. Front Public Health. 2025 Oct 22;13:1688158. doi: 10.3389/fpubh.2025.1688158. eCollection 2025.
PubMed 41200026
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPOSITION (EXPosome, Oxidative Stress and InflammaTION) in Persons With Multiple Sclerosis Study
- ClinicalTrials.gov ID
- NCT06325358
- Acronym / sponsor ID
- EXPOSITION / 0040083/23
- Keywords
- multiple sclerosis, exposome, microRNA, cytokines, microbiome, neurofilament, air pollution, urbanization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- National Research Council (Consiglio Nazionale delle Ricerche), IRCCS National Neurological Institute "C. Mondino" Foundation
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Multiple sclerosis | – | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
microRNAs
Time frame: from March 2024 to July 2024 visit
The differential expression of a set of 7 specific circulating plasma microRNAs from the blood of each pwMS will be measured. The set of miRNAs has been already selected based on their significant deregulated expression in MS, as evidenced in a bioinformatic analysis conducted using computational resources. A portion of serum samples will be collected and immediately frozen at -20°C. After being transported, serum samples will be thawed and the circulating RNAs will be extracted. After a step of microRNA specific reverse transcription, the copy-DNA obtained will be used as the template for Real Time-qPCR analyses of selected miRNAs by Singleplex TaqMan microRNA assay reactions.The method of Livak et al. will be applied for the comparative analysis of the relative expression of the selected microRNAs in serum samples, considering different combinations of the external exposome variables.
Air quality
Time frame: from March 2023 to July 2023
Spatial information on pollutants such as PM10, PM2.5, PM1.0 expressed in microg/m3, nanoparticulate (n/cm3), and black carbon (microg/m3) from CAMS and CHIMBO databases and from Sentinel-5P TROPOMI will be included as gridded emissions in 0.1° x 0.1° (long-lat) resolution for the whole time series (daily values), from March 2023 onwards from the Pavia and Milano provinces. Large Eddy Simulations will be carried out over such areas with a high spatial-temporal resolution for estimating - in a quantitative manner - the 3D pollutants concentration at the street level.The grid will be further subdivided into the municipalities of the two provinces and a "personal exposure" will be also assessed, based on the geographic position of each pwMS derived from the residence address (geo-positioning).
Nutritional assessment
Time frame: from March 2024 to July 2024
The dietary habits of the participants will be evaluated with the use of a validated food frequency questionnaire (FFQ) adapted to the Italian population and adjusted based on current food trends, such as the consumption of plant-based milk and meat. Detailed information about the daily food consumption of pwMS will be gained through a 24-h dietary recall.
Neurofilament (NfL)
Time frame: from March 2024 to July 2024
Human NfL will be assessed on plasma samples by Simple Plex assay (ProteinSimple, CA, USA) on Ella device (ProteinSimple, CA, USA), according to the manufacturer's instructions. Calibration of Ella will be performed using the incartridge factory standard curve, and plasma samples will be measured with a 1:2 dilution in Sample Diluent (ProteinSimple, CA, USA). A single well was used for each sample as triplicates assays are automatically performed in Simple Plex assay microfluidic platform. The LLOQ is 2.70 pg/ml; the upper limit of quantification is 10,290.00 pg/ml.
Cytokines
Time frame: from March 2024 to July 2024
Serum levels of IL1-beta, IL2, IL4, IL6, IL-10, IL12, IL17, IL22, IL23, TGF-beta, GM-CSF, TNF-alpha, IFN-gamma expressed in pg/mL will be assessed by using CXCL10 (performed using Simple Plex , R\&D and commercial ELISA kit).
the Body Mass Index (BMI)
Time frame: from March 2024 to July 2024
Weight in kg and height in m will be measured in order to calculate the Body Mass Index (BMI) as the ratio of weight (kg) to height (m) squared.
Physical activity
Time frame: from March 2024 to July 2024
Physical activity levels will be evaluated by using the International Physical Activity Questionnaires (IPAQ) . The questionnaire is composed of 7 questions concerning the last 7 days levels of moderate, vigorous and sedentary physical activity. The metabolic equivalent of tasks (MET) will be calculated using the frequency and duration of physical activity and will be reported as MET-min/wk.
Quality of life related to MS
Time frame: from March 2024 to July 2024
Quality of life will be evaluated by Multiple Sclerosis Quality of Life-29 (MSQOL-29), a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.
Sleep Quality
Time frame: from March 2024 to July 2024
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire. The questionnaire consists of 9 multiple-choice items divided into 5 different components related to subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction. The global PSQI score will be obtained by considering the scores of all the components and it ranges from 0 to 13. The PSQI cut-off of 5 or above indicates poor sleep quality.
Smoking habits
Time frame: from March 2024 to July 2024
Cigarette smoking habits will be registered considering patients who are smoking, never smoked and quit smoking. The number of cigarettes smoked per day and the years of smoking will be recorded for smokers. Ex-smokers will be asked the number of years not smoking, the number of years that have smoked and the number of cigarettes smoked per day during their smoking years.
Dietary supplements use
Time frame: from March 2024 to July 2024
Dietary supplements use will be assessed based on the type and nutrients included in the dietary supplements, their dose and their frequency of use.
Adherence to Mediterranean diet
Time frame: from March 2024 to July 2024
Adherence to the Mediterranean dietary model will be assessed by applying the MEDI-LITE score. The MEDI-LITE score is based on a questionnaire, which investigates the frequency of consumption of nine classes of food. The final score varies from 0 (low adherence) to 18 (high adherence). Overall, subjects who will obtain a score higher than 9 will have a significantly increased adherence to the Mediterranean Diet.
Effect of diet on inflammation
Time frame: from March 2024 to July 2024
The Dietary Inflammatory Index (DII) will be also calculated to quantify the overall effect of diet on inflammatory potential. The DII will be calculated based on the daily food consumption and then based on it the food parameters included in DII will be evaluated, such as vitamins, macronutrients, minerals, green/black tea and others.
waist and height ratio (WHtR)
Time frame: from March 2024 to July 2024
The waist circumference and (cm) height (cm) will be measured in order to calculate their ratio (WHtR), a good predictor of abdominal adiposity in adults, will be also calculated.
Bioelectrical impedance
Time frame: from March 2024 to July 2024
Bioelectrical impedance analysis will be used for the analysis of phase angle (PhA), which is considered an indicator of cellular health and malnutrition.
1 secondary outcome
Microbiome and biological biomarkers of oxidative stress and inflammation
Time frame: from March 2024 to July 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 41200026Monti MC, De Giuseppe R, Bertoli G, Alemayohu MA, Al-Naqeb G, Ballante E, Bergamaschi R, Camboni T, Ceccarani C, Ceriani C, Colombo E, Consolandi C, Costabile F, Decesari S, Gallivanone F, Galuzzi BG, Gastaldi M, Gervasoni C, Gugiatti S, Itri T, Kalmpourtzidou A, Landi TC, Lanzotti A, Dico AL, Loperfido F, Maccarini B, Mazza A, Montomoli C, Oddone E, Paulin N, Pellizzer C, Pernetti R, Scarabotto A, Sellaro F, Severgnini M, Summa D, Vivone G, Porro D, Cena H, Tavazzi E. Exposome, oxidative stress and inflammation in persons with multiple sclerosis: the EXPOSITION study protocol. Front Public Health. 2025 Oct 22;13:1688158. doi: 10.3389/fpubh.2025.1688158. eCollection 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis, Relapsing-Remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
The HIt HArd and hiT Early in Multiple Sclerosis Trial
Relapsing-remitting Multiple Sclerosis
RecruitingPhase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
RecruitingObservational study
Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis
Relapse Remitting Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleonora Tavazzi principal investigator
Neurological Institute-Foundation IRCCS Casimiro Mondino, Pavia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting and Environmental Exposure, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleonora Tavazzi (0382380403 ext. +39, eleonora.tavazzi@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microRNAs (time frame: from March 2024 to July 2024 visit). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06325358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.