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RECRUITING
NCT05920018
NA

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

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Vivomixx®

Daily application of four sachets, i.e. 1.800 bio bacteria/day for 48 weeks

DIETARY_SUPPLEMENT

Conjugated linoleic acid (CLA/Tonalin® FFA 80)

Daily application of two capsules p.o., i.e. 2g/day for 48 weeks

OTHER

Maltose placebo

Daily application of four sachets for 48 weeks

OTHER

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