RecruitingNot ApplicableNCT05920018

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


Sponsor

Universität Münster

Enrollment

100 participants

Start Date

Oct 2, 2023

Study Type

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking two dietary supplements — conjugated linoleic acid (CLA, a fatty acid found in dairy) and a probiotic called Vivomixx — alongside standard first-line immune-modifying medications can help reduce relapses in people with relapsing-remitting multiple sclerosis (RRMS). RRMS is the most common form of MS, where periods of worsening symptoms are followed by recovery. **You may be eligible if:** - You have relapsing-remitting multiple sclerosis (RRMS) diagnosed according to current guidelines - You have a disability level (EDSS score) of 5.5 or lower - You are 18–60 years old - You have been on a stable first-line MS treatment (interferon-beta, teriflunomide, or glatiramer acetate) for at least 6 months - You have not had a relapse in the past 3 months **You may NOT be eligible if:** - You have primary or secondary progressive MS - You have taken stronger MS medications such as natalizumab, fingolimod, ocrelizumab, or alemtuzumab recently - You are already taking dietary supplements (vitamins, probiotics, omega-3 fatty acids, etc.) - You have significant gut problems (such as inflammatory bowel disease) - You are pregnant or breastfeeding - You follow a strictly vegan diet (which may affect supplement absorption) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTVivomixx®

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

DIETARY_SUPPLEMENTConjugated linoleic acid (CLA/Tonalin® FFA 80)

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

OTHERMaltose placebo

Daily application of four sachets for 48 weeks

OTHERSunflower 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

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NCT05920018


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