In short
Lactobacillus helveticus is a probiotic bacterium found in the hard capsule product Lacidofil. It is part of a fixed combination with Lactobacillus rhamnosus, strain LCR35. The substance was being tested in one Phase 2 clinical trial for multiple sclerosis, which planned to enroll 210 participants but has since been withdrawn.
Key points
- Lactobacillus helveticus is a probiotic bacterium contained in the hard capsule product Lacidofil.
- The product is authorised as a medicine in Poland (authorisation record PL R/2350) and held by LALLEMAND SAS.
- It was studied in one Phase 2 clinical trial for multiple sclerosis.
- The trial planned to enroll 210 participants but has been withdrawn.
- The trial was to compare Trilac vs Lacidofil vs a control group in reducing clinical activity of multiple sclerosis.
- The primary outcome was the annualized relapse rate (ARR) at 12 and 24 months.
What is lactobacillus helveticus?
Lactobacillus helveticus is a probiotic bacterium. In the product records for the clinical trial described on this page, it appears as part of a fixed combination with Lactobacillus rhamnosus, strain LCR35, live. The combination product is sold under the name Lacidofil, kapsułki, twarde (hard capsules). The product is authorised as a medicine in Poland, with authorisation record PL R/2350, and the authorisation holder is LALLEMAND SAS. The substance is classified in the therapeutic areas of nervous system diseases and immune system diseases.
How does lactobacillus helveticus work?
The registry data provided for this page does not include a description of the mechanism of action of lactobacillus helveticus. As a probiotic, it is a live bacterium, but no further information on how it might act in multiple sclerosis is available in the sources used here.
Which conditions is lactobacillus helveticus used or studied for?
- Multiple sclerosis — the one clinical trial listed for this substance was studying whether the probiotic combination could reduce the clinical activity of multiple sclerosis.
No other conditions are mentioned in the data provided.
How is lactobacillus helveticus given?
The pharmaceutical form of the product containing lactobacillus helveticus is a hard capsule, and the route of administration is oral. In the trial, the intervention was listed as Lacidofil, kapsułki, twarde at a strength of 10,000,000,000 CFU/g (colony forming units per gram).
What do the clinical trials show?
There is one clinical trial in the data for lactobacillus helveticus: a Phase 2, multicenter, randomised, open-label trial in multiple sclerosis. The trial was titled "PRObiotic Therapy Examining Combinatorial Therapeutics in Multiple Sclerosis". It planned to enroll 210 participants. The trial status is Withdrawn, meaning the study was stopped before it started recruiting participants.
The trial was designed to compare the effectiveness of Trilac versus Lacidofil versus a control group in reducing the clinical activity of multiple sclerosis. Other interventions listed in the trial included Kesimpta (ofatumumab) 20 mg solution for injection and Zeposia (ozanimod) hard capsules, which are authorised medicines for multiple sclerosis.
Who can take part in these trials?
The data provided does not include detailed eligibility criteria for the withdrawn trial. Because the trial was withdrawn, no participants were enrolled.
What are the trials measuring?
The primary outcome for the trial was the annualized relapse rate (ARR) at the end of month 12 and month 24. The annualized relapse rate is the average number of multiple sclerosis relapses a person has per year. A lower ARR indicates fewer relapses and less clinical disease activity.