Status:
RECRUITING
The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
NA
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 pa...
Eligibility Criteria
Inclusion
- Patients aged 18-55 years, inclusive
- 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
- Relapse the month before enrollment
- 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
Key Trial Info
Start Date :
July 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07168772
Start Date
July 10 2025
End Date
December 31 2027
Last Update
September 23 2025
Active Locations (1)
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1
Centre d'Esclerosi Mútiple de Catalunya (Cemcat)
Barcelona, Barcelona, Spain, 08035