Multiple Sclerosis
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLactibane Iki
Patients will receive a probiotic sachet twice a day for six months. The probiotic, Lactibiane iki (Pileje; Paris, France), is composed of Bifidobacterium lactis LA 304, Lactobacillus acidophilus LA 201, and Lactobacillus salivarius LA 302 and contains 4x10E10 CFU/sachet.
OTHERPlacebo
Patients will receive a placebo (starch) sachet twice a day for six months.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in the percentage of Treg cells | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs | 6 months | Immunological profile studied by flow cytometry (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs. |
| Serum levels of NfL, GFAP, cytokines and CRP | 6 months | Serum levels of NfL and GFAP quantified using a commercially available ultra-sensitive single molecule enzyme-linked immunoarray (SIMOA, Quanterix). |
| Serum and fecal levels of SCFAs | 6 months | Serum and fecal levels of SCFAs analyzed using a liquid chromatography tandem mass spectrometry (LC-MS/MS) system. |
| Microbiota composition analysis | 6 months | Bioinformatic analysis of the microbiome by the analysis of the total DNA extraction and sequencing of fecal samples and negative control sample. |
Countries
Spain
Outcome results
None listed