Multiple Sclerosis
Conditions
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.
Interventions
OTHERMagnetic resonance imaging (MRI)
MRI scanner
Sponsors
National MS Center Melsbroek
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evidence for active disease | 3 years | Time to first relapse (after baseline) will be reported for all patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Belgium
Outcome results
None listed