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 18-55 years, inclusive
Diagnosis of RRMS (McDonald Criteria 2017 and Lublin phenotype classification 2014)
Expanded disability status scale (EDSS) score less than or equal to 5.5
Patients receiving a first line treatment with teriflunomide or dimethyl fumarate at a stable dose, for at least 24 weeks, or patients who are not receiving treatment because they do not want to receive a DMT after the investigator has informed them of their possible respective benefits and possible adverse events
Relapse the month before enrollment
Presence of a new lesion, indicative of radiological activity, on the MRI performed before starting the study
Use of corticosteroids the month before enrollment
Use of antibiotics three months before enrollment