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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

NCT05920018 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Universität Münster

    lead OTHER

Principal Investigators

  • Luisa Klotz, Prof. · Universität Münster

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05920018 on ClinicalTrials.gov