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
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||520 participants|
|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|
- 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.
- 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
- Clinical metadata, including: Consent form; Medications; annual relapse rate;
- Blood tests, including a complete blood count, complete biochemistry, lipid profile, cholesterol profile;
- 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.
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
|Contact: Anat Achiron, MD, PhDemail@example.com|
|Contact: Eran Segal, PhD||972542239989||Eran.Segal@weizmann.ac.il|
|Principal Investigator:||Anat Achiron, MD, PhD||Sheba Medical Center|