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 (CLAProMS)

Universität Münster

Status: Enrolling

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Dietary Supplement: Vivomixx®; Other: Maltose placebo; Dietary Supplement: Conjugated linoleic acid (CLA/Tonalin® FFA 80); Other: Sunflower oil placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05920018

WWU21_0013

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Dietary supplement

Active Comparator group

Description:

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)

Treatment:

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

Dietary Supplement: Vivomixx®

Placebo-control

Placebo Comparator group

Description:

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

Treatment:

Other: Maltose placebo

Other: Sunflower oil placebo