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
NCT ID: NCT05920018
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-10-02
2025-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dietary supplement
1. Vivomixx®/VSL#3 sachets p.o. (1.800 bio bacteria/d) and
2. Conjugated linoleic acid (CLA/Tonalin® FFA 80) capsules p.o. (2 g/d)
Vivomixx®
Daily application of four sachets, i.e. 1.800 bio bacteria/day for 48 weeks
Conjugated linoleic acid (CLA/Tonalin® FFA 80)
Daily application of two capsules p.o., i.e. 2g/day for 48 weeks
Placebo-control
1. Maltose as Placebo to Vivomixx® and
2. Sunflower oil as Placebo to Conjugated linoleic acid (CLA/Tonalin® FFA 80)
Maltose placebo
Daily application of four sachets for 48 weeks
Sunflower oil placebo
Daily application of two capsules p.o for 48 weeks
Interventions
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Vivomixx®
Daily application of four sachets, i.e. 1.800 bio bacteria/day for 48 weeks
Conjugated linoleic acid (CLA/Tonalin® FFA 80)
Daily application of two capsules p.o., i.e. 2g/day for 48 weeks
Maltose placebo
Daily application of four sachets for 48 weeks
Sunflower oil placebo
Daily application of two capsules p.o for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Universität Münster
OTHER
Responsible Party
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Principal Investigators
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Luisa Klotz, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universität Münster
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Brigitte Wildemann, Prof.
Role: primary
Susanne Windhagen, Dr.
Role: primary
Other Identifiers
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WWU21_0013
Identifier Type: -
Identifier Source: org_study_id
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