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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
Sponsor: Universität Münster
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-10-02
Completion Date
2025-02
Last Updated
2024-05-08
Healthy Volunteers
No
Conditions
Interventions
Vivomixx®
Daily application of four sachets, i.e. 1.800 bio bacteria/day for 48 weeks
Conjugated linoleic acid (CLA/Tonalin® FFA 80)
Daily application of two capsules p.o., i.e. 2g/day for 48 weeks
Maltose placebo
Daily application of four sachets for 48 weeks
Sunflower oil placebo
Daily application of two capsules p.o for 48 weeks
Locations (4)
Universitätsklinik Heidelberg, Neurologische Klinik
Heidelberg, Baden-Wurttemberg, Germany
Neurological study centre, Department of Neurology
Mainz, Hesse, Germany
IIT unit of the Department of Neurology with Institute of Translational Neurology
Münster, North Rhine-Westphalia, Germany
Klinikum Osnabrück GmbH, Klinik für Neurologie
Osnabrück, North Rhine-Westphalia, Germany