LACTOBACILLALES for Multiple sclerosis|Relapsing-remitting multiple sclerosis

Inclusion criteria

• {"criterion_text":"- Multiple sclerosis diagnosed according to McDonald's criteria from 2017."}
• {"criterion_text":"- Age 18-45 years inclusive."}
• {"criterion_text":"- Consent to participate in the study."}
• {"criterion_text":"- No steroids treatment in the past 3 months."}
• {"criterion_text":"- Minimum of 6 months history of MS treatment with ozanimod or ofatumumab."}

Exclusion criteria

• {"criterion_text":"- Unable or not willing to comply with the protocol regulations."}
• {"criterion_text":"- Participation in other clinical trial during the participation in this trial."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Antibiotics, oral or intravenous immunosuppressive in the past 3 months."}
• {"criterion_text":"- History of chronic infectious disease (e.g., TBC, HIV, HBV, HCV, etc.)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Pregnancy or lactation."}
• {"criterion_text":"- Primary multiple sclerosis."}
• {"criterion_text":"- Known allergic reaction to one of the probiotics: Trilac or Lacidofil."}
• {"criterion_text":"- History of other immunomodulatory MS treatment than ozanimod or ofatumumab."}
• {"criterion_text":"- 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)."}

Primary endpoints

• {"endpoint_text":"- Annualized Relapse Rate (ARR) at the end of month 12 and 24.","definition_or_measurement_approach":"Measured as Annualized Relapse Rate (ARR) assessed at the end of month 12 and month 24."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients with no clinical evidence of disease activity (NEDA) [Time Frame: Baseline month 12, month 24]","definition_or_measurement_approach":"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. Time frames: baseline, month 12, month 24."}
• {"endpoint_text":"- Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months [Time Frame: 24-month period].","definition_or_measurement_approach":"Mean number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan over the 24-month period."}
• {"endpoint_text":"- The 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].","definition_or_measurement_approach":"Mean per-scan number based on cumulative new/enlarging T2 lesions since baseline over 24 months."}
• {"endpoint_text":"- Mean Number of Gadolinium Enhancing Brain Lesions at Month 12, Month 24 [Time Frame: 24-month period].","definition_or_measurement_approach":"Mean number of gadolinium-enhancing brain lesions measured at month 12 and month 24."}
• {"endpoint_text":"- The number of gadolinium-enhancing (GdE) lesions at 12 month and 24 months. [Time Frame: 24-month period]","definition_or_measurement_approach":"Count of Gd-enhancing lesions at month 12 and month 24 over the 24-month period."}
• {"endpoint_text":"- Change in mental health evaluated by the GHQ-28 questionnaire in MS patients receiving Trilac vs Lacidofil vs the control group.","definition_or_measurement_approach":"Change in GHQ-28 questionnaire scores comparing Trilac, Lacidofil and control groups."}
• {"endpoint_text":"- Difference in severity of feeling pain measured by VAS scale in MS patients receiving Trilac vs Lacidofil vs the control group.","definition_or_measurement_approach":"Difference in pain severity measured by Visual Analogue Scale (VAS) between groups."}
• {"endpoint_text":"- Difference in severity of fatigue in MS patients receiving Trilac vs Lacidofil vs the control group. Fatigue will be evaluated by Fatigue Analogue Scale.","definition_or_measurement_approach":"Fatigue assessed using the specified fatigue analogue scale (FSS referenced in translation) comparing groups."}
• {"endpoint_text":"- Change in quality of life measured by SF-36 questionnaire in MS patients receiving Trilac vs Lacidofil vs the control group.","definition_or_measurement_approach":"Change in SF-36 quality-of-life questionnaire scores comparing Trilac, Lacidofil and control groups."}
• {"endpoint_text":"- Percentage of adverse events.","definition_or_measurement_approach":"Proportion/percentage of participants experiencing adverse events."}

Poland

Earliest CTIS Part Ii Submission Date

09-09-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

41

Number Of Sites

1

Number Of Participants

210

Primary sponsor

Full Name

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland