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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Universitätsklinik Heidelberg, Neurologische Klinik
RECRUITING
Heidelberg
Neurological study centre, Department of Neurology
RECRUITING
Mainz
IIT unit of the Department of Neurology with Institute of Translational Neurology
RECRUITING
Münster
Klinikum Osnabrück GmbH, Klinik für Neurologie
RECRUITING
Osnabrück
Contact Information
Primary
Luisa Klotz, Prof.
MS-Studienambulanz@ukmuenster.de
+49 (0)251 83
Backup
Jan Lünemann, Prof.
MS-Studienambulanz@ukmuenster.de
+49 (0)251 83
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2025-02
Participants
Target number of participants: 100
Treatments
Active_comparator: 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)
Placebo_comparator: Placebo-control
1. Maltose as Placebo to Vivomixx® and~2. Sunflower oil as Placebo to Conjugated linoleic acid (CLA/Tonalin® FFA 80)
Related Therapeutic Areas
Sponsors
Leads: Universität Münster

This content was sourced from clinicaltrials.gov