Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Magnetic resonance imaging (MRI)

• Registration Number: NCT03797937
• Lead Sponsor: National MS Center Melsbroek

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.

Study Timeline

• Study First Submitted: 2018-03-05
• Study Start: 2018-11-01
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-09
• Primary Completion: 2021-11-01
• Status Verified: 2022-05
• Study Completion: 2022-05-01
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple sclerosis (MS) patients	Magnetic resonance imaging (MRI)	Patients will undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

Primary Outcome Measures

Name	Time	Method
Clinical evidence for active disease	3 years	Time to first relapse (after baseline) will be reported for all patients.

Secondary Outcome Measures

Name	Time	Method
Radiological evidence for active disease	3 years	Occurrence of new contrast-enhancing T1 hyper intense lesions, or changes in white matter lesion volume (i.e. new or enlarging T2 hyper intense lesions)

Trial Locations

Locations (2)

Nationaal Multiple Sclerose Centrum Melsbroek; 🇧🇪 Melsbroek, Vlaams-Brabant, Belgium

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussel, Belgium