PRObiotic Therapy Examining Combinatorial Therapeutics in Multiple Scl
PRObiotic Therapy Examining Combinatorial Therapeutics in Multiple Sclerosis - phase II, multicenter, randomised, open-label clinical trial.
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- LACTOBACILLALES
- LACTOBACILLUS HELVETICUS, LACTOBACILLUS RHAMNOSUS, STRAIN LCR35, LIVE
What it measured
Main measures
Annualized Relapse Rate (ARR) at the end of month 12 and 24.
Relapses
Other measures (10)
Percentage of patients with no clinical evidence of disease activity (NEDA) [Time Frame: Baseline month 12, month 24] NEDA is defined by no confirmed MS relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening.
Disability progressionRelapsesMRI lesionsMean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months [Time Frame: 24-month period].
MRI lesionsThe mean number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan based on the cumulative number of new or enlarging T2 lesions since baseline over 24 months. [Time Frame: 24-month period].
MRI lesionsMean Number of Gadolinium Enhancing Brain Lesions at Month 12, Month 24 [Time Frame: 24-month period].
MRI lesionsThe number of gadolinium-enhancing (GdE) lesions at 12 month and 24 months. [Time Frame: 24-month period]
MRI lesionsChange in mental health evaluated by the GHQ-28 questionnaire in MS patients receiving Trilac vs Lacidofil vs the control group.
Difference in severity of feeling pain measured by VAS scale in MS patients receiving Trilac vs Lacidofil vs the control group.
PainDifference in severity of fatigue in MS patients receiving Trilac vs Lacidofil vs the control group. Fatigue will be evaluated by Fatigue Analogue Scale.
FatigueChange in quality of life measured by SF-36 questionnaire in MS patients receiving Trilac vs Lacidofil vs the control group.
Quality of life (reported by participants)Percentage of adverse events.
Safety
Who could take part
MS (type not specified) · 18 to 64
Show the full criteria
Inclusion criteria
- Multiple sclerosis diagnosed according to McDonald's criteria from 2017. - Age 18-45 years inclusive. - Consent to participate in the study. - No steroids treatment in the past 3 months. - Minimum of 6 months history of MS treatment with ozanimod or ofatumumab.
Exclusion criteria
- Unable or not willing to comply with the protocol regulations. - History of other immunomodulatory MS treatment than ozanimod or ofatumumab. - Lack of consent for using highly effective contraception during treatment with ozanimod or ofatumumab and at least for 3 months after last administration of ozanimod or at least for 6 months after last administration of ofatumumab (for women of childbearing potential only). - Participation in other clinical trial during the participation in this trial. - Elapsed time of less than 5 half-lives since the last administration of investigational medicinal product in another clinical trial, as of the date of patient randomization (visit 0). - Antibiotics, oral or intravenous immunosuppressive in the past 3 months. - History of chronic infectious disease (e.g., TBC, HIV, HBV, HCV, etc.). - Active or history of cancer within the past 5 years, except for basal-cell carcinoma of the skin and carcinoma in situ of cervix in patients who have received radical treatment. - Pregnancy or lactation. - Primary multiple sclerosis. - Known allergic reaction to one of the probiotics: Trilac or Lacidofil.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Comparison of the effectiveness of Trilac vs Lacidofil vs control group in reducing the clinical activity of multiple sclerosis.
Loading reviews and guidelines…
History
Started
Sept 2025
Finished
May 2030