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

RecruitingNA

Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Conditions: Multiple Sclerosis

Interventions: Lactibane Iki, Placebo

Countries: Spain

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Barcelona, Barcelona, Spain