It is a randomized, double-blind, placebo-controlled clinical trial whose general objective of this study is to determine the effects of probiotic administration in multiple sclerosis patients.
80 patients with relapsing-remitting multiple sclerosis will be enrolled in the study. Patients will be randomly assigned to receive either a probiotic (n=40) or a placebo (n=40) stratified by type of medication, gender and use of hormonal contraceptive treatment. They will receive a probiotic (Lactibane Iki) or placebo sachet twice a day for six months.
Patients aged 18-60 years, inclusive
Diagnosis of RRMS (McDonald Criteria 2024, Montalban et al)
Expanded disability status scale (EDSS) score less than or equal to 5.5
Patients receiving a first line treatment with teriflunomide, dimethyl fumarate, interferon-beta or glatiramer acetate at a stable dose, for at least 24 weeks, or patients who are not receiving treatment because they do not want to receive a disease modifying therapy after the investigator has informed them of their possible respective benefits and possible adverse events
Relapse the month before enrollment
Use of corticosteroids the month before enrollment
Use of antibiotics three months before enrollment
Taking other forms of symbiotic, probiotic, prebiotic and postbiotic supplements three months before enrollment
Parallel
Lactibane Iki
Dietary supplementPatients will receive a probiotic sachet twice a day for six months. The probiotic, Lactibiane iki (Pileje; Paris, France), is composed of Bifidobacterium lactis LA 304, Lactobacillus acidophilus LA 201, and Lactobacillus salivarius LA 302 and contains 4x10E10 CFU/sachet.
Placebo
Other interventionPatients will receive a placebo (starch) sachet twice a day for six months.
Increase in the percentage of Treg cells
Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs
Immunological profile studied by flow cytometry (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs.
Serum levels of NfL, GFAP, cytokines and CRP
Serum levels of NfL and GFAP quantified using a commercially available ultra-sensitive single molecule enzyme-linked immunoarray (SIMOA, Quanterix).
Serum and fecal levels of SCFAs
Serum and fecal levels of SCFAs analyzed using a liquid chromatography tandem mass spectrometry (LC-MS/MS) system.
Microbiota composition analysis
Bioinformatic analysis of the microbiome by the analysis of the total DNA extraction and sequencing of fecal samples and negative control sample.
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