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Status:

COMPLETED

Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

Lead Sponsor:

National MS Center Melsbroek

Conditions:

Multiple Sclerosis

Eligibility:

All Genders

18-55 years

Phase:

NA

Brief Summary

The goal of this longitudinal study is to (1) explore the association between the gut microbiota and inflammatory disease activity in early onset multiple sclerosis, (2) investigate whether/how gut mi...

Detailed Description

Using metagenomics, as well as clinical, immunological, and radiological observations, the investigators will investigate if active relapsing-remitting multiple sclerosis patients have a more pro-infl...

Eligibility Criteria

Inclusion

  • Inclusion Criteria patients:
  • Diagnosis of MS (as defined by the 2010 McDonald criteria).
  • Occurrence of symptoms no longer than 5 years before baseline.
  • Aged 18-65.
  • Willingness to participate in the study and to sign the informed consent.
  • Exclusion Criteria patients:
  • Treatment with high doses of systemic steroids 2 months before baseline.
  • Use of antibiotics 3 months before baseline.
  • Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer).
  • Other immune-mediated or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1 and 2, psoriasis).
  • Additional inclusion criteria for MS patients undergoing a relapse:
  • • Ability to provide a faecal sample within 4 weeks from onset of the first symptoms suggestive of a relapse, before cortisone treatment. A relapse is defined by a new clinical sign or clinical worsening of a previous sign/symptom persisting for \>=24 hours in the absence of fever.
  • Additional exclusion criteria for MS patients undergoing a relapse:
  • Treatment with cortisone before collection of baseline faecal sample.
  • Evidence of a relapse less than 2 months before baseline.
  • Switching disease modifying treatment less than 2 months before baseline.
  • Inclusion criteria healthy controls:
  • Willingness to participate to the study and to sign the informed consent.
  • Aged \>=18.
  • Exclusion criteria healthy controls:
  • Neurodegenerative disorders.
  • Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer) or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1, psoriasis).
  • Use of antibiotics 3 months before baseline.
  • Treatment with high doses of systemic steroids 2 months before baseline.

Exclusion

    Key Trial Info

    Start Date :

    November 1 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2022

    Estimated Enrollment :

    250 Patients enrolled

    Trial Details

    Trial ID

    NCT03797937

    Start Date

    November 1 2018

    End Date

    May 1 2022

    Last Update

    May 11 2022

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Universitair Ziekenhuis Brussel

    Jette, Brussels Capital, Belgium, 1090

    2

    Nationaal Multiple Sclerose Centrum Melsbroek

    Melsbroek, Vlaams-Brabant, Belgium, 1820