Overview
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.
Eligibility
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