The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactibane Iki, Placebo.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Overview
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 supplement Lactibane 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. - Other Placebo
Patients will receive a placebo (starch) sachet twice a day for six months.
Primary outcome measures
- Increase in the percentage of Treg cells [Time frame: 6 months]
Secondary outcome measures (4)
- Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs [Time frame: 6 months]
- Serum levels of NfL, GFAP, cytokines and CRP [Time frame: 6 months]
- Serum and fecal levels of SCFAs [Time frame: 6 months]
- Microbiota composition analysis [Time frame: 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Centre d'Esclerosi Mútiple de Catalunya (Cemcat) — Barcelona
Identifiers
NCT: NCT07168772 · PROBiMS