The Effect of a Probiotic Administration as an add-on Treatment in Mul
The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
What it found
No result yet.
What was tested
Treatment tested
- Lactibane Iki
Placebo
- Placebo
What it measured
Main measures
Increase in the percentage of Treg cells
6 months
Other measures (4)
Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs
6 months
Serum levels of NfL, GFAP, cytokines and CRP
6 months
Blood or spinal fluid markersImmune responseSerum and fecal levels of SCFAs
6 months
Microbiota composition analysis
6 months
Who could take part
Relapsing MS · 18 to 60
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Jul 2025
Main results due
Dec 2027
Finished
Dec 2027