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PRObiotic Therapy Examining Combinatorial Therapeutics in Multiple Sclerosis - phase II, multicenter, randomised, open-label clinical trial.
EU CTIS ID: 2025-520955-10-00
What this study is testing
Comparison of the effectiveness of Trilac vs Lacidofil vs control group in reducing the clinical activity of multiple sclerosis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.