The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis
Recruiting · NCT07168772 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Lactibane IkiPlacebo
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Centre d'Esclerosi Mútiple de Catalunya (Cemcat) - Barcelona, Barcelona, Spain