Probiotic added to treatment for relapsing-remitting multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.