The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis

Inclusion criteria

• 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
• At enrollment, the patient is not expected to require a change in DMT
• Patients showing a maximum of two new lesions on MRI prior to inclusion
• Females of childbearing potential must have a negative urine pregnancy test result prior to initiation of study product
• For females of childbearing potential: agreement to use adequate contraceptive methods during the treatment period
• Ability to comply with the study protocol
• Patients must sign and date a written informed consent prior to entering the study

Exclusion criteria

• 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
• Taking other forms of symbiotic, probiotic, prebiotic and postbiotic supplements three months before enrollment
• Patients suffering from any type of bowel disease
• Pregnant or breastfeeding or intending to become pregnant during the study.
• Be menopausal
• Be a smoker