Probiotic added to treatment for relapsing-remitting multiple sclerosis
The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
This trial will test whether taking a probiotic twice daily for six months helps adults with relapsing-remitting multiple sclerosis who are on certain medications or not on disease-modifying therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona, Barcelona) |
| Trial ID | NCT07168772 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial will enroll 80 adults with relapsing-remitting multiple sclerosis and assign them to Lactibane Iki probiotic or matching placebo twice daily for six months. Randomization is stratified by current medication, gender, and hormonal contraceptive use. Eligible participants are 18–55 years old with EDSS ≤5.5 and either on a stable dose of teriflunomide or dimethyl fumarate for at least 24 weeks or electing not to use a DMT, with limited MRI activity prior to enrollment. Clinical, imaging, and laboratory measures will be compared between groups to determine the probiotic's effects.
Who should consider this trial
Good fit: Adults 18–55 with relapsing-remitting MS, EDSS ≤5.5, either on a stable dose of teriflunomide or dimethyl fumarate for at least 24 weeks or not taking a DMT by choice, and willing to attend the Barcelona site are ideal candidates.
Not a fit: Patients with progressive MS, EDSS >5.5, those on other or unstable disease-modifying therapies, pregnant people, or those unable to attend the single site in Barcelona are unlikely to qualify or benefit.
Why it matters
Potential benefit: If effective, the probiotic could offer a low-cost, well-tolerated add-on that may improve symptoms or reduce inflammatory activity in RRMS.
How similar studies have performed: Small pilot trials and preclinical studies have reported some immunologic changes and symptom signals with probiotics in MS, but results are mixed and not yet conclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Barcelona, Barcelona
- Centre d'Esclerosi Mútiple de Catalunya (Cemcat) — Barcelona, Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.