Overview
The goal of this randomized, double-blind, placebo-controlled multicenter study is to investigate whether the combination of food supplementation with Tonalin® and specific probiotics is a safe and effective add-on to first-line disease modifying treatment (DMT, interferon-beta derivatives as well as glatirameracetate and other glatirameroids) in relapsing remitting MS (RRMS).
100 patients will be randomly assigned in a 1:1 ratio to receive either both food supplements for 48 weeks or to receive placebo in addition to their established first-line disease modifying treatment (DMT). The two randomized groups will be compared concerning the change in volume of T2-weighted hyperintense lesions from baseline to 48 weeks.
Eligibility
Inclusion Criteria:
- Relapsing-remitting multiple sclerosis according to current McDonald Criteria, EDSS maximal 5.5, 18-60 years
- stable treatment with first-line DMT (IFNbeta, teriflunomide or glatiramer acetate/ other glatirameroids) for at least 6 months
- absence of a clinical relapse for at least 3 months before inclusion
- Written informed consent
Exclusion Criteria:
- diagnosis of primary or secondary progressive MS or other active autoimmune disease
- intake/administration of the following disease modifying therapies:
- at any time point: alemtuzumab, cladribine
- during the last 6 months before inclusion: natalizumab, fingolimod, dimethyl fumarate, siponimod
- during the last 12 months before inclusion: mitoxantron, ocrelizumab, ofatumumab, rituximab
- ingestion of other dietary supplementation (e.g. vitamins, probiotics, iron, calcium,
prebiotics, such as omega-3-fatty acids)
- significant gastroenterological abnormality (e.g. inflammatory bowel disease, short bowel disease, preexisting digestive lesions)
- accompanying systemic immunosuppressive treatment
- relevant dietary restriction (e.g. strictly vegan nutrition)
- women during pregnancy or lactation