Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Universität Münster
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-arm, randomized, double-blind, placebo-controlled, multicenter
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of volume of 'hyperintense lesions in the T2-weighted MRI images' between baseline and after 48 weeks of therapy
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in T2 lesions at 48 weeks compared to baseline
timeFrame: 48 weeks
measure: Number of new or enlarging T2-weighted hyperintense lesions
timeFrame: 48 weeks
measure: Volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' as well as double inversion recovery (DIR) images
timeFrame: 48 weeks
measure: Annualized relapse rate
timeFrame: 48 weeks
Other outcomes:
measure: Disease progression throughout the study
timeFrame: 48 weeks
measure: Assessment of patient-reported outcomes (PRO) and quality of life via MSIS-29 (Multiple Sclerosis Impact Scale)
timeFrame: 48 weeks
measure: Assessment of patient-reported outcomes (PRO) and quality of life via FSMC (Fatigue Scale for Motion and Cognition)
timeFrame: 48 weeks
measure: Assessment of patient-reported outcomes (PRO) and quality of life via SDMT (Symbol-Digit Modalities Test)
timeFrame: 48 weeks
measure: Assessment of patient-reported outcomes (PRO) and quality of life via HADS (Hospital Anxiety and Depression Scale)
timeFrame: 48 weeks
measure: Assessment of patient-reported outcomes (PRO) and quality of life via BDI-II (Beck's Depression Inventory)
timeFrame: 48 weeks
measure: Assessment of patient-reported outcomes (PRO) and quality of life via TSQM-9 (Treatment Satisfaction Questionnaire for Medication)
timeFrame: 48 weeks
measure: Changes in key peripheral blood immune signatures
timeFrame: 48 weeks
measure: Focus on signs of gastrointestinal and systemic side effects
timeFrame: 48 weeks
measure: Functional characterization of human myeloid cells
timeFrame: 48 weeks
measure: Correlation of identified immunological effects with main endpoints of MRI and clinical efficacy
timeFrame: 48 weeks
measure: Changes in diffuse white matter damage (measured by fractional anisotropy FA)
timeFrame: 48 weeks
measure: Global brain atrophy, grey matter atrophy and white matter atrophy
timeFrame: 48 weeks
Locations:
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg, Neurologische Klinik
state: BW
city: Mainz
country: Germany
facility: Neurological study centre, Department of Neurology
state: Hessen
city: Münster
country: Germany
facility: IIT unit of the Department of Neurology with Institute of Translational Neurology
state: NRW
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück GmbH, Klinik für Neurologie
state: NRW
Study officials:
affiliation: Universität Münster
name: Luisa Klotz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: