Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

NCT ID: NCT03797937

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2022-05-01

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Multiple sclerosis (MS) patients

Patients will undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

Group Type: EXPERIMENTAL

Magnetic resonance imaging (MRI)

Intervention Type: OTHER

MRI scanner

Healthy controls

Healthy controls will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Multiple sclerosis (MS) patients undergoing a relapse

Multiple sclerosis (MS) patients undergoing a relapse will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Multiple sclerosis (MS) patients from multiplex MS families

Multiple sclerosis (MS) patients from multiplex MS families will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Magnetic resonance imaging (MRI)

MRI scanner

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Willingness to participate to the study and to sign the informed consent.
• Aged >=18.

Exclusion Criteria

• 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).

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National MS Center Melsbroek

OTHER

Sponsor Role: lead

Responsible Party

Marie D'hooghe

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie D'hooghe, M.D.

Role: PRINCIPAL_INVESTIGATOR

National MS Center Melsbroek

Locations

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Nationaal Multiple Sclerose Centrum Melsbroek

Melsbroek, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

2018BDM2

Identifier Type: -

Identifier Source: org_study_id