Actively Recruiting
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
Led by Universität Münster · Updated on 2024-05-08
100
Participants Needed
4
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsing-remitting multiple sclerosis diagnosed by current McDonald Criteria with EDSS score up to 5.5
- Age between 18 and 60 years
- Stable treatment with first-line disease modifying therapy (interferon-beta, teriflunomide, glatiramer acetate, or other glatirameroids) for at least 6 months
- No clinical relapse for at least 3 months before joining the study
- Provided written informed consent
You will not qualify if you...
- Diagnosis of primary or secondary progressive multiple sclerosis or other active autoimmune diseases
- Use of certain disease modifying therapies: alemtuzumab or cladribine at any time; natalizumab, fingolimod, dimethyl fumarate, or siponimod within 6 months before joining; mitoxantron, ocrelizumab, ofatumumab, or rituximab within 12 months before joining
- Use of other dietary supplements such as vitamins, probiotics, iron, calcium, prebiotics, or omega-3 fatty acids
- Significant gastrointestinal disorders like inflammatory bowel disease, short bowel syndrome, or existing digestive lesions
- Ongoing systemic immunosuppressive treatment
- Strict dietary restrictions such as vegan nutrition
- Women who are pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Universitätsklinik Heidelberg, Neurologische Klinik
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
2
Neurological study centre, Department of Neurology
Mainz, Hesse, Germany
Actively Recruiting
3
IIT unit of the Department of Neurology with Institute of Translational Neurology
Münster, North Rhine-Westphalia, Germany
Actively Recruiting
4
Klinikum Osnabrück GmbH, Klinik für Neurologie
Osnabrück, North Rhine-Westphalia, Germany, 49076
Actively Recruiting
Research Team
L
Luisa Klotz, Prof.
CONTACT
J
Jan Lünemann, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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