Effects of a Combined Supplementation of Conjugated Linoleic Acid (CLA) and Probiotics (Vivomixx®) as add-on to a First-line Immunotherapy in Relapsing-remitting Multiple Sclerosis
Effects of a Combined Supplementation of Conjugated Linoleic Acid (CLA/Tonalin® FFA 80) and Probiotics (Vivomixx®/VSL#3) as add-on to a First-line Immunotherapy in Relapsing-remitting Multiple Sclerosis
Universität Münster
100 participants
Oct 2, 2023
INTERVENTIONAL
Conditions
Summary
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 Criteria9
- 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
- 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
Exclusion Criteria3
- 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
Interventions
Daily application of four sachets, i.e. 1.800 bio bacteria/day for 48 weeks
Daily application of two capsules p.o., i.e. 2g/day for 48 weeks
Daily application of four sachets for 48 weeks
Daily application of two capsules p.o for 48 weeks
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05920018