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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Dietary Supplement: Vivomixx®; Other: Maltose placebo; Dietary Supplement: Conjugated linoleic acid (CLA/Tonalin® FFA 80); Other: Sunflower oil placebo

• Registration Number: NCT05920018
• Lead Sponsor: Universität Münster

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-27
• Study Start: 2023-10-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary supplement	Vivomixx®	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-control	Maltose placebo	1. Maltose as Placebo to Vivomixx® and 2. Sunflower oil as Placebo to Conjugated linoleic acid (CLA/Tonalin® FFA 80)
Dietary supplement	Conjugated linoleic acid (CLA/Tonalin® FFA 80)	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-control	Sunflower oil placebo	1. Maltose as Placebo to Vivomixx® and 2. Sunflower oil as Placebo to Conjugated linoleic acid (CLA/Tonalin® FFA 80)

Primary Outcome Measures

Name	Time	Method
Change of volume of 'hyperintense lesions in the T2-weighted MRI images' between baseline and after 48 weeks of therapy	48 weeks	The two randomised study groups (intervention and placebo groups) are compared with regard to the change of volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' (hereafter T2 lesions) between the start of the study and after 48 weeks.; T2 lesions were chosen as primary endpoint as this has been used as a surrogate marker of efficacy in several recent MS studies

Secondary Outcome Measures

Name	Time	Method
Change in T2 lesions at 48 weeks compared to baseline	48 weeks	Change in T2 lesions at 48 weeks compared to baseline (yes/no)
Volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' as well as double inversion recovery (DIR) images	48 weeks	Volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' as well as double inversion recovery (DIR) images will be compared between the intervention arm and the placebo arm. This approach has been recently published and rises the probability to detect new brain lesions in MS without application of gadolinium with a sensitivity of 98.1%
Annualized relapse rate	48 weeks	All relapses confirmed by a physician will be documented and analysed. Clinical relapses are defined as onset of new or recurrent neurological symptoms lasting at least 24 hours, accompanied by objective abnormalities on a neurological examination, which are not explained solely by non-MS processes such as fever, infection, severe stress or drug toxicity. Annualized relapse rates are compared between the two study groups.
Number of new or enlarging T2-weighted hyperintense lesions	48 weeks	Number of new or enlarging T2-weighted hyperintense lesions based on the comparison of brain MRI-scans after 48 weeks of intervention as compared to baseline

Trial Locations

Locations (4)

Universitätsklinik Heidelberg, Neurologische Klinik; 🇩🇪 Heidelberg, BW, Germany

Neurological study centre, Department of Neurology; 🇩🇪 Mainz, Hessen, Germany

IIT unit of the Department of Neurology with Institute of Translational Neurology; 🇩🇪 Münster, NRW, Germany

Klinikum Osnabrück GmbH, Klinik für Neurologie; 🇩🇪 Osnabrück, NRW, Germany