NCT05920018

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universität Münster · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vivomixx®	Daily application of four sachets, i.e. 1.800 bio bacteria/day for 48 weeks
DIETARY_SUPPLEMENT	Conjugated linoleic acid (CLA/Tonalin® FFA 80)	Daily application of two capsules p.o., i.e. 2g/day for 48 weeks
OTHER	Maltose placebo	Daily application of four sachets for 48 weeks
OTHER	Sunflower oil placebo	Daily application of two capsules p.o for 48 weeks

Timeline

• Start date: 2023-10-02
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2023-06-27
• Last updated: 2024-05-08

Locations

4 sites across 1 country: Germany