Effects of a Combined Supplementation of Conjugated Linoleic Acid (CLA
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
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Vivomixx®
- Conjugated linoleic acid (CLA/Tonalin® FFA 80)
Placebo
- Maltose placebo
- Sunflower oil placebo
What it measured
Main measures
Change of volume of 'hyperintense lesions in the T2-weighted MRI images' between baseline and after 48 weeks of therapy
48 weeks
MRI lesions
Other measures (4)
Change in T2 lesions at 48 weeks compared to baseline
48 weeks
MRI lesionsNumber of new or enlarging T2-weighted hyperintense lesions
48 weeks
MRI lesionsVolume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' as well as double inversion recovery (DIR) images
48 weeks
MRI lesionsAnnualized relapse rate
48 weeks
Relapses
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
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: 1. at any time point: alemtuzumab, cladribine 2. during the last 6 months before inclusion: natalizumab, fingolimod, dimethyl fumarate, siponimod 3. 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Oct 2023
Main results due
Feb 2025
Finished
Feb 2025