NCT07168772RecruitingNot Applicable
The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Hospital Universitari Vall d'Hebron Research Institute2 sites in 1 country80 target enrollmentStarted: July 10, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Increase in the percentage of Treg cells
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Lactibane Iki
Experimental
Intervention: Lactibane Iki (Dietary Supplement)
Placebo
Placebo Comparator
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Increase in the percentage of Treg cells
Time Frame: 6 months
Increase in the percentage of Treg cells
Time Frame: 6 months
Secondary Outcomes
- Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs(6 months)
- Serum levels of NfL, GFAP, cytokines and CRP(6 months)
- Serum and fecal levels of SCFAs(6 months)
- Microbiota composition analysis(6 months)
- Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs(6 months)
- Serum levels of NfL, GFAP, cytokines and CRP(6 months)
- Serum and fecal levels of SCFAs(6 months)
- Microbiota composition analysis(6 months)
Investigators
Study Sites (2)
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