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Recruiting Not applicable

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

NCT07168772 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2025-07-10
Last updated
2026-08-07

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Lactibane IkiPlacebo

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.

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

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Increase in the percentage of Treg cells — 6 months

Trial sites (1)

FacilityCityRegionStatus
Centre d'Esclerosi Mútiple de Catalunya (Cemcat) Barcelona Barcelona Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07168772 on ClinicalTrials.gov ↗ ← All trials in Spain