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 | Recruiting

• 1 other identifier: WWU21_0013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

• Change of volume of 'hyperintense lesions in the T2-weighted MRI images' between baseline and after 48 weeks of therapy

  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

  48 weeks

Secondary Outcomes (4)

• Change in T2 lesions at 48 weeks compared to baseline

  48 weeks

• Number of new or enlarging T2-weighted hyperintense lesions

  48 weeks

• Volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' as well as double inversion recovery (DIR) images

  48 weeks

• Annualized relapse rate

  48 weeks

Other Outcomes (13)

• Disease progression throughout the study

  48 weeks

• Assessment of patient-reported outcomes (PRO) and quality of life via MSIS-29 (Multiple Sclerosis Impact Scale)

  48 weeks

• Assessment of patient-reported outcomes (PRO) and quality of life via FSMC (Fatigue Scale for Motion and Cognition)

  48 weeks

Study Arms (2)

Dietary supplement

ACTIVE COMPARATOR

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)

Dietary Supplement: Vivomixx®; Dietary Supplement: Conjugated linoleic acid (CLA/Tonalin® FFA 80)

Placebo-control

PLACEBO COMPARATOR

1. Maltose as Placebo to Vivomixx® and 2. Sunflower oil as Placebo to Conjugated linoleic acid (CLA/Tonalin® FFA 80)

Other: Maltose placebo; Other: Sunflower oil placebo

Interventions

Vivomixx® DIETARY_SUPPLEMENT

Daily application of four sachets, i.e. 1.800 bio bacteria/day for 48 weeks

Dietary supplement

Conjugated linoleic acid (CLA/Tonalin® FFA 80) DIETARY_SUPPLEMENT

Daily application of two capsules p.o., i.e. 2g/day for 48 weeks

Dietary supplement

Maltose placebo OTHER

Daily application of four sachets for 48 weeks

Placebo-control

Sunflower oil placebo OTHER

Daily application of two capsules p.o for 48 weeks

Placebo-control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Written informed consent

You may not qualify if:

• diagnosis of primary or secondary progressive MS or other active autoimmune disease
• intake/administration of the following disease modifying therapies:
• at any time point: alemtuzumab, cladribine
• 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

Sponsors & Collaborators

• Universität Münster: lead

Study Sites (4)

Universitätsklinik Heidelberg, Neurologische Klinik

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Neurological study centre, Department of Neurology

Mainz, Hesse, Germany

RECRUITING

IIT unit of the Department of Neurology with Institute of Translational Neurology

Münster, North Rhine-Westphalia, Germany

RECRUITING

Klinikum Osnabrück GmbH, Klinik für Neurologie

Osnabrück, North Rhine-Westphalia, 49076, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Linoleic Acids, Conjugated

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Linoleic Acids; Fatty Acids, Omega-6; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Luisa Klotz, Prof.

  Universität Münster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luisa Klotz, Prof.

CONTACT

+49 (0)251 83; MS-Studienambulanz@ukmuenster.de

Jan Lünemann, Prof.

CONTACT

+49 (0)251 83; MS-Studienambulanz@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized after successful screening and inclusion. They will be randomized with a 1:1 ratio to receive either conjugated linoleic acid (CLA/Tonalin®) and probiotics (Vivomixx®) or the corresponding placebos as add-on therapy. Randomization will be stratified according to first-line therapy with Interferon-beta, Glatirameracetat / other glatirameroids, or Teriflunomid.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-arm, randomized, double-blind, placebo-controlled, multicenter

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 27, 2023
• Study Start: October 2, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

DE (4)