Tests a probiotic add-on in people with relapsing-remitting multiple sclerosis
Tests a probiotic supplement, added to usual care, in adults with multiple sclerosis.
Plain-language title generated from the registry record
Registry title: The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis
Key facts
- Where
- Barcelona, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07168772, who can take part
Where in Spain
- Centre d'Esclerosi Mútiple de Catalunya (Cemcat)Barcelona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitari Vall d'Hebron Research Institute
- Trial code
- NCT07168772
- Record updated
- 7 August 2026
- Original description
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.Read full original descriptionShow less
The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Inclusion: 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: 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.