Pylopass™: Benefits, Dosage, Contraindications

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Pylopass™ is a strain of Lactobacillus reuteri (DSM 17648) containing more than ≥ 1 x100 billion inactivated cells/gram. Lactobacillus reuteri specifically binds to H. pylori in the stomach. The adhesion molecules on the surface of Pylopass™ recognize and attach to the surface of Helicobacter pylori. There is formation of aggregates in the stomach which are then excreted through the digestive tract and eliminated from the body. Helicobacter pylori is a human pathogen infecting about 50% of the world's population. The average prevalence in developed countries among individuals under 40 years of age is 20%, whereas developing countries have a prevalence rate of 80 to 90%. Helicobacter pylori is associated with a number of gastrointestinal diseases, such as peptic ulcers, gastritis, and gastric cancer. The effectiveness of using probiotics in the prevention and treatment of various gastrointestinal diseases has been widely demonstrated in clinical studies. It has been found that not only live probiotics but also dead cells or even cell fractions seem sufficient to modify biological responses. The development of the inactivated DSMZ17648 Lactobacillus strain offers preventive options for patients by reducing the risk of ulcers or gastric cancer.

Other name(s) 

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Scientific name(s)

Lactobacillus reuteri DSMZ1764

Family or group: 

Probiotics


Indications

Rating methodology

EFSA approval.

Several clinical trials (> 2) randomized controlled with double blind, including a significant number of patients (>100) with consistently positive outcomes for the indication.
Several clinical trials (> 2) randomized controlled with double blind, and including a significant number of patients (>100) with positive outcomes for the indication.
One or more randomized studies or multiple cohorts or epidemiological studies with positive outcomes for the indication.
Clinical studies exist but are uncontrolled, with conclusions that may be positive or contradictory.
Lack of clinical studies to date that can demonstrate the indication.


Helicobacter pylori infection
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Clinical studies using Pylopass in monotherapy (daily dose of 2×10 billion non-viable cells in two doses, after breakfast and dinner) on TRU (Urea Breath Test) positive subjects, asymptomatic or with clinical signs showed: - A variable eradication rate between 10% and 50% depending on the studies. - A significant reduction in Helicobacter pylori colonization in more than half of participants by the 14th day of treatment. - A reduction in the degree of inflammation in 25 to 28.6% of cases. - A significant decrease in dyspepsia symptoms, in both proportion and severity, from the 14th day of treatment. - Stabilization of positive results over time, as assessed by TRU over 24 weeks after treatment. There is also some evidence on the use of L. reuteri as an adjuvant to standard eradication therapy (omeprazole 40 mg/day, amoxicillin 2000 mg/day, clarithromycin 1000 mg/day), which increases effectiveness and reduces the incidence of adverse effects. In the group of patients receiving the standard treatment combined with L. reuteri, the efficacy was 80% compared to 60% in the placebo group. In patients treated with L. reuteri, the incidence of adverse effects significantly decreased, mainly nausea and diarrhea.

Posologie

posologieOral route

posologie100 UI


Properties


Gastroprotective

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In a placebo-controlled, single-blind study, oral intake for 2 weeks of non-viable freeze-dried Lactobacillus reuteri DSM17648 cells significantly reduced the H. pylori load. Lactobacillus reuteri DSM17648 interferes with the mobility of H. pylori and its adherence to gastric mucosa by entangling the cells in aggregates and masking the surface sites of H. pylori that are normally available for binding to human epithelium. The binding is due to specific surface molecules on the cells of Lactobacillus reuteri DSM17648. These molecules are resistant to freeze-drying or spray drying, as demonstrated in the study. Once bound, the co-aggregates will be expelled from the stomach through the natural movement of the intestines.

Usages associés

Helicobacter pylori infection


Safety dosage

Adult: 100 UI

Daily dose of 100 Billion non-viable cells in two doses, after breakfast and dinner. 1 UI = billion CFUs (Colony Forming Unit)