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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Daily application of four sachets, i.e. 1.800 bio bacteria/day for 48 weeks
Daily application of two capsules p.o., i.e. 2g/day for 48 weeks
Daily application of four sachets for 48 weeks
Daily application of two capsules p.o for 48 weeks
Universitätsklinik Heidelberg, Neurologische Klinik
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGNeurological study centre, Department of Neurology
Mainz, Hesse, Germany
RECRUITINGIIT unit of the Department of Neurology with Institute of Translational Neurology
Münster, North Rhine-Westphalia, Germany
RECRUITINGKlinikum Osnabrück GmbH, Klinik für Neurologie
Osnabrück, North Rhine-Westphalia, Germany
RECRUITINGChange 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
Time frame: 48 weeks
Change in T2 lesions at 48 weeks compared to baseline
Change in T2 lesions at 48 weeks compared to baseline (yes/no)
Time frame: 48 weeks
Number of new or enlarging T2-weighted hyperintense lesions
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
Time frame: 48 weeks
Volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' as well as double inversion recovery (DIR) images
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%
Time frame: 48 weeks
Annualized relapse rate
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.
Time frame: 48 weeks
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