The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis
NCT ID: NCT07168772
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-07-10
2027-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lactibane Iki
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.
Placebo
Placebo
Patients will receive a placebo (starch) sachet twice a day for six months.
Interventions
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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.
Placebo
Patients will receive a placebo (starch) sachet twice a day for six months.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of RRMS (McDonald Criteria 2017 and Lublin phenotype classification 2014)
* Expanded disability status scale (EDSS) score less than or equal to 5.5
* Patients receiving a first line treatment with teriflunomide or dimethyl fumarate at a stable dose, for at least 24 weeks, or patients who are not receiving treatment because they do not want to receive a DMT after the investigator has informed them of their possible respective benefits and possible adverse events
* At enrollment, the patient is not expected to require a change in DMT
* Patients showing a maximum of two new lesions on MRI prior to inclusion
* 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
* Presence of a new lesion, indicative of radiological activity, on the MRI performed before starting the study
* 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.
* Be menopausal
* Be a smoker
18 Years
55 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Locations
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Centre d'Esclerosi Mútiple de Catalunya (Cemcat)
Barcelona, Barcelona, Spain
Countries
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Facility Contacts
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Other Identifiers
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PROBiMS
Identifier Type: -
Identifier Source: org_study_id
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