Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

Multiple Sclerosis Clinical Trial

Official title:

Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797937
• Other study ID #: 2018BDM2
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: National MS Center Melsbroek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Magnetic resonance imaging (MRI)
MRI scanner

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussel
Belgium	Nationaal Multiple Sclerose Centrum Melsbroek	Melsbroek	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
National MS Center Melsbroek

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evidence for active disease	Time to first relapse (after baseline) will be reported for all patients.	3 years
Secondary	Radiological evidence for active disease	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)	3 years