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

The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial

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.

Inclusion Criteria:

• 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
• Not active RRMS patients (Lubin et al, 2014) for whom a switch in background therapy is not anticipated, based on the Investigator's judgment.
• At enrollment, the patient is not expected to require a change in DMT
• 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
• 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.