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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form prior to entering the study Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

Lactibane Iki

Patients 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.

OTHER

Placebo

Patients will receive a placebo (starch) sachet twice a day for six months.

Locations (1)

Centre d'Esclerosi Mútiple de Catalunya (Cemcat)
Barcelona, Barcelona, Spain