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Clinical Trials/NCT03797937
NCT03797937
Completed
Not Applicable

Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

National MS Center Melsbroek2 sites in 1 country250 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
National MS Center Melsbroek
Enrollment
250
Locations
2
Primary Endpoint
Clinical evidence for active disease
Status
Completed
Last Updated
3 years ago

Overview

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 microbial composition vary when patients experience a relapse, and (3) to assess whether the gut microbiota shows increased similarities between affected pairs of first-degree relatives within the same family when compared with discordant pairs of first-degree relatives.

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-inflammatory gut microbiota signature than multiple sclerosis patients with less active disease and matched healthy controls. More specifically, the investigators will investigate whether temporal variability of the gut microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes in the gut microbiota are predictive of future inflammatory disease activity in multiple sclerosis, and whether gut microbiota characteristics are predictive of the disease course after 2 years.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
May 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National MS Center Melsbroek
Responsible Party
Principal Investigator
Principal Investigator

Marie D'hooghe

Prof. Dr.

National MS Center Melsbroek

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Clinical evidence for active disease

Time Frame: 3 years

Time to first relapse (after baseline) will be reported for all patients.

Secondary Outcomes

  • Radiological evidence for active disease(3 years)

Study Sites (2)

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