An observational study in Multiple Sclerosis, sponsored by National MS Center Melsbroek. Completed at 2 sites in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-23.
Sponsored by National MS Center Melsbroek · Observational
This study aims to assess the following research questions:
This study is a prospective multi-center cohort study (University Hospital Brussels, National Multiple Sclerosis Center Melsbroek). This is an exploratory study and there is no specific outcome on which a power calculation can be made. We will include different subgroups of patients with MS: stable non-benign RRMS, PPMS, benign MS [Benign MS is defined as RRMS with an EDSS ≤ 3, 15 years after disease onset], RRMS during a relapse (before the administration of corticosteroids) [Relapses are defined as the development of new or recurrent neurologic symptoms not associated with fever or infection or change in medication, lasting at least 24 hours, and accompanied by new, objective neurologic findings]. Age and sex matched healthy controls will be included as well. All participants will provide a faecal, hair, and blood sample twice (baseline and after 3 months). Patients will be assessed clinically at baseline, 3 months after baseline, and approximately 1, 2, 4.5 years after baseline.
The results of this study have the potential to identify novel simple strategies to strengthen or alter the microbiome ecosystem and strengthen the overall treatment process. In case of a positive result, this would form the basis for a follow-up study on medical modulation of the microbiome with the aim of finding new treatment options for MS.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 152 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →National MS Center Melsbroek is the lead sponsor of 5 studies on the registry; none are open to participants now.
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This is an exploratory study and there is no specific outcome on which a power calculation can be made. We included 122 patients with MS and 30 age and sex matched healthy controls as well.
Exclusion Criteria:
No intervention will be administered. Stool, hair, and blood samples will be collected at baseline and three months post baseline. Clinical follow-up will occur at year 1, 2, and 4.5 (neurological consultation) and in-between visits (regular follow-up).
Sustained disability worsening
Sustained disability worsening will be assessed using the Expanded Disability Status Scale (EDSS)-Plus outcome. This is a composite measure that assesses disability worsening based on changes of the EDSS score (difference of at least 1.5;1.0;0.5 depending on baseline score), the timed 25-foot walk (T25FW) score (\>=20%), and the 9-hole peg test (9-HPT) score (\>=20%). If worsening of any of these measures occurred, the patient has clinically deteriorated according to the EDSS-Plus outcome.
Time frame: 5 years
Clinical evidence for active disease
Time to first relapse (after baseline) will be reported for all patients. Annualized relapse frequency
Time frame: 5 years
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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National MS Center Melsbroek