Combining CLA and Probiotics with Immunotherapy for 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
This study is testing whether adding conjugated linoleic acid and probiotics to standard treatment can help people with relapsing-remitting multiple sclerosis feel better and improve their MRI results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Universität Münster Academic / other |
| Drugs / interventions | alemtuzumab, natalizumab, ocrelizumab, ofatumumab, rituximab |
| Locations | 4 sites (Heidelberg, Baden-Wurttemberg and 3 other locations) |
| Trial ID | NCT05920018 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled multicenter study aims to evaluate the safety and effectiveness of combining conjugated linoleic acid (CLA) and probiotics with first-line immunotherapy in patients with relapsing-remitting multiple sclerosis (RRMS). A total of 100 participants will be randomly assigned to receive either the supplements or a placebo alongside their established disease-modifying treatment for 48 weeks. The primary outcome will be the change in volume of T2-weighted hyperintense lesions measured through MRI from baseline to the end of the study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a diagnosis of relapsing-remitting multiple sclerosis who have been stable on first-line disease-modifying treatment for at least six months.
Not a fit: Patients with primary or secondary progressive MS or those on certain other disease-modifying therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of existing immunotherapies for patients with relapsing-remitting multiple sclerosis.
How similar studies have performed: While the combination of dietary supplements with immunotherapy is a novel approach, similar studies have shown promising results in enhancing treatment efficacy in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heidelberg, Baden-Wurttemberg and 3 other locations
- Universitätsklinik Heidelberg, Neurologische Klinik — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
- Neurological study centre, Department of Neurology — Mainz, Hesse, Germany (Recruiting)
- IIT unit of the Department of Neurology with Institute of Translational Neurology — Münster, North Rhine-Westphalia, Germany (Recruiting)
- Klinikum Osnabrück GmbH, Klinik für Neurologie — Osnabrück, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Luisa Klotz, Prof. — Universität Münster
- Study coordinator: Luisa Klotz, Prof.
- Email: MS-Studienambulanz@ukmuenster.de
- Phone: +49 (0)251 83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.