In short
Lactobacillales is a probiotic substance being studied in a Phase 2 clinical trial for multiple sclerosis, a condition affecting the nervous system. The trial was designed to enroll 210 participants and compare lactobacillales with other probiotics and standard multiple sclerosis treatments, but it has been withdrawn. Lactobacillales is already authorised as a medicine in some records and belongs to a group of bacteria commonly known as lactic acid bacteria.
Key points
- Lactobacillales is a probiotic being tested in multiple sclerosis in a Phase 2 trial.
- The trial was withdrawn before it started, so no results are available.
- It was planned as a multicentre, randomised, open-label study with 210 participants.
- The main goal was to measure the annualized relapse rate at 12 and 24 months.
- Lactobacillales is taken by mouth and is already authorised as a medicine in some records.
What is lactobacillales?
Lactobacillales is a probiotic substance, meaning it contains live bacteria that may have health effects when taken by mouth. It belongs to a large group of bacteria called lactic acid bacteria, which are commonly found in fermented foods and in the human gut. In the CTIS product records, lactobacillales is described as a structurally diverse substance of biological origin, not a chemically synthesised drug.
The substance is also known by the name lactobacillales and has been authorised as a medicine in some records, although the specific authorisation details are not listed in the trial data. It is distinct from specific probiotic strains such as Lactobacillus fermentum LfQi6, which has been evaluated by the US Food and Drug Administration as generally recognised as safe for use as a food ingredient.
How does lactobacillales work?
The exact way lactobacillales might work in multiple sclerosis is not described in the available sources. Probiotics like lactobacillales are generally thought to influence the community of bacteria in the gut, which in turn may affect the immune system. Because multiple sclerosis is a condition in which the immune system attacks the protective covering of nerves, researchers have explored whether changing the gut bacteria could alter immune activity.
However, the trial record for lactobacillales does not state a specific mechanism of action, and the supplementary sources do not describe how this particular probiotic preparation acts in the body.
Which conditions is lactobacillales studied for?
- Multiple sclerosis — a long-lasting disease of the central nervous system in which the immune system damages the protective layer around nerve fibres, leading to symptoms such as fatigue, difficulty walking, and vision problems. The withdrawn Phase 2 trial was designed to test whether lactobacillales could reduce disease activity in people with this condition.
How is lactobacillales given?
Lactobacillales is taken by mouth. In the trial record, the intervention is listed as an oral preparation with a strength of 8,000,000,000 colony forming units per gram. The trial also included another probiotic, Lacidofil, as a comparison, given as hard capsules by mouth.
What do the clinical trials show?
One clinical trial of lactobacillales is listed in the EU Clinical Trials Information System. It was a Phase 2, multicentre, randomised, open-label study planned to include 210 participants with multiple sclerosis.
The trial was designed to compare the effectiveness of lactobacillales (referred to as Trilac in the summary) with another probiotic called Lacidofil and with a control group. The main outcome measure was the annualized relapse rate, which counts how many relapses a person with multiple sclerosis has per year, assessed at the end of month 12 and month 24.
However, the trial has been withdrawn, meaning it did not go ahead as planned. No results are available, so it is not possible to say whether lactobacillales has any effect on multiple sclerosis based on this study.
What side effects are known?
The available sources do not report specific side effects for lactobacillales. The FDA GRAS notice for the related strain Lactobacillus fermentum LfQi6 concluded that it is generally recognised as safe for use as a food ingredient, which suggests a favourable safety profile for that specific strain, but this does not directly describe the lactobacillales preparation studied in the withdrawn multiple sclerosis trial.