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Deciphering the Role of the Gut Microbiota in Multiple Sclerosis

NCT02580435 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 520

Last updated 2015-10-29

No results posted yet for this study

Summary

Multiple sclerosis (MS) is an inflammatory disease that affects the nervous system and results in a wide range of signs and symptoms including physical and cognitive problems. Recent evidence demonstrates that interactions between the host immune system and the commensal gut microbiota have a key role in the development of the disease. However, the natures of these interactions are poorly studied, and the set of bacteria with pathogenic or protective potential are unknown. Here, the investigators propose a multi-pronged approach to deciphering the role of the microbiota in MS, by developing microbiome-based machine learning algorithms aimed at: (1) distinguishing healthy individuals from MS patients; (2) predicting the time since the onset of MS in relation to disease activity by predicting next relapse and neurological progression; (3) identifying microbiome signatures that characterize the relapse state; (4) distinguishing various MS phenotypes in relation to blood and microbiome transcriptome signatures; (5) predicting response to various immunomodulatory treatments in relation to blood and microbiome transcriptome signatures. Overall, these studies should establish the role of the microbiome in multiple sclerosis, resulting in a set of non-invasive tools for characterization of the disease; identification of the kinetics of MS using microbiome as a readout; and allowing the prediction of individuals prone to MS based on their microbiome and in relation to their protein expression. These new set of diagnostic and predictive tools may thus add a novel and unexplored dimension to the study of the disease that may lead in the future to new therapeutic avenues based on designing microbiome-targeted interventions.

Conditions

Sponsors & Collaborators

  • Weizmann Institute of Science

    collaborator OTHER

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Anat Achiron, MD, PhD · Sheba Medical Center

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2020-12-31
Completion
2021-12-31

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Entities

Diseases

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 NCT02580435 on ClinicalTrials.gov