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The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT07168772•Hospital Universitari Vall d'Hebron Research Institute

View on ClinicalTrials.gov

Summary

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

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Centre d'Esclerosi Mútiple de Catalunya (Cemcat)

Barcelona, Barcelona, Spain

Key Dates

Start Date

July 10, 2025

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

September 23, 2025

Enrollment

ESTIMATED participants

Conditions

Multiple Sclerosis

Interventions

Lactibane Iki

DIETARY_SUPPLEMENT

Placebo

OTHER

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

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RECRUITINGNA

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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Intermittent Hypoxia in Persons With Multiple Sclerosis

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