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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT07168772
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-10
• Study First Submitted: 2025-08-26
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-04
• Study First Posted: 2025-09-11
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-23
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Increase in the percentage of Treg cells	6 months

Secondary Outcome Measures

Name	Time	Method
Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs	6 months	Immunological profile studied by flow cytometry (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs.
Serum levels of NfL, GFAP, cytokines and CRP	6 months	Serum levels of NfL and GFAP quantified using a commercially available ultra-sensitive single molecule enzyme-linked immunoarray (SIMOA, Quanterix).
Serum and fecal levels of SCFAs	6 months	Serum and fecal levels of SCFAs analyzed using a liquid chromatography tandem mass spectrometry (LC-MS/MS) system.
Microbiota composition analysis	6 months	Bioinformatic analysis of the microbiome by the analysis of the total DNA extraction and sequencing of fecal samples and negative control sample.

Trial Locations

Locations (1)

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