Actively Recruiting
The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2025-09-23
80
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-55 years, inclusive
- Diagnosis of relapsing-remitting multiple sclerosis by established criteria
- Expanded Disability Status Scale (EDSS) score of 5.5 or less
- Receiving stable first line treatment with teriflunomide or dimethyl fumarate for at least 24 weeks, or not receiving disease-modifying treatment by choice
- No expected need to change disease-modifying treatment at enrollment
- Maximum of two new lesions on MRI prior to inclusion
- Negative urine pregnancy test for females of childbearing potential before starting study product
- Agreement to use effective contraception during treatment for females of childbearing potential
- Ability to comply with study procedures
- Signed informed consent prior to study entry
You will not qualify if you...
- Relapse within the month before enrollment
- New lesion indicating active disease on MRI before study start
- Use of corticosteroids within the month before enrollment
- Use of antibiotics within three months before enrollment
- Use of other symbiotic, probiotic, prebiotic, or postbiotic supplements within three months before enrollment
- Presence of any bowel disease
- Pregnancy, breastfeeding, or intention to become pregnant during the study
- Menopausal status
- Current smoking
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre d'Esclerosi Mútiple de Catalunya (Cemcat)
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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