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Deciphering the Role of the Gut Microbiota in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02580435
Recruitment Status : Not yet recruiting
First Posted : October 20, 2015
Last Update Posted : October 29, 2015
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by (Responsible Party):
Prof. Anat Achiron, Sheba Medical Center

Brief 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.

Condition or disease
Multiple Sclerosis

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Study Type : Observational
Estimated Enrollment : 520 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Deciphering the Role of the Gut Microbiota in Multiple Sclerosis
Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 1. Change in expression of intestinal microbiome composition between MS patients and healthy controls. [ Time Frame: 5 years ]
    Intestinal microbiome composition and function of a cohort of 50 untreated early MS patients, up to 12 months from onset, untreated with immunomodulatory drugs or steroids for at least 3 months, as well as 50 age-, sex-, and diet-matched healthy controls (obtained from the Weizmann DataBank) will be performed.

  2. Change in microbiome expression intestinal microbiome composition between MS patients phenotypes. [ Time Frame: 5 years ]
    Intestinal microbiome composition and function and blood profiling of 100 patients with different disease phenotypes (RIS=20; CIS=30; RRMS=30; PPMS=20) will be performed.


Biospecimen Retention:   Samples Without DNA

From each patient, the investigarors will obtain

  1. Clinical metadata, including: Consent form; Medications; annual relapse rate;
  2. Blood tests, including a complete blood count, complete biochemistry, lipid profile, cholesterol profile;
  3. Gut microbiota profile obtained from stool samples will be processed for shotgun metagenomic sequencing and 16S rRNA profiling. Gut microbiota profiling will be done from stool samples that will be immediately flash-frozen in liquid nitrogen and preserved at a minimum of -80oC until further processing.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The Multiple Sclerosis Center at Sheba Medical Center is currently following and treating 3710 out of ~5000 MS patients in Israel and as such represents a unique opportunity to unravel the role of the microbiome in MS, since it offers the possibility to identify multiple subgroups of patients in an attempt to detect microbiome signatures. A total of 520 subjects will be included in the study as is further specified. The data for 100 healthy control subjects will be obtained from the Weizmann DataBank by Prof Eran Segal.
Criteria

Inclusion Criteria:

  • Diagnosis of RIS, CIS, RRMS, PPMS.
  • Signed written informed consent.

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Severe cognitive decline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580435


Contacts
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Contact: Anat Achiron, MD, PhD 97235303932 anat.achiron@sheba.health.gov.il
Contact: Eran Segal, PhD 972542239989 Eran.Segal@weizmann.ac.il

Sponsors and Collaborators
Sheba Medical Center
Weizmann Institute of Science
Investigators
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Principal Investigator: Anat Achiron, MD, PhD Sheba Medical Center
Publications:

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Responsible Party: Prof. Anat Achiron, Director & Chair, Multiple Sclerosis Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02580435    
Other Study ID Numbers: 2356-15-SMC
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Keywords provided by Prof. Anat Achiron, Sheba Medical Center:
multiple sclerosis
microbiome
prediction
outcome
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases