Pylopass™: benefits, dosage, contraindications

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Pylopass™ is a strain of Lactobacillus reuteri (DSM 17648) containing ≥ 1 x100 billion inactivated cells/gram. Lactobacillus reuteri binds specifically to H. pylori in the stomach. Adhesion molecules on the surface of Pylopass™ recognize and adhere 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 that infects about 50% of the world’s population. The average prevalence in developed countries among people under 40 years old is 20%, whereas developing countries have a prevalence rate of 80–90%. Helicobacter pylori is associated with a number of gastrointestinal diseases, such as gastroduodenal ulcer, 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 appear sufficient to modify biological responses. The development of the inactivated Lactobacillus DSMZ17648 strain makes it possible to offer preventive options to patients by reducing the risk of ulcer or gastric cancer.

Scientific name(s)

Lactobacillus reuteri DSMZ1764

Family or group: 

Probiotics


Indications

Scoring methodology

EFSA approval.

Several randomized, double-blind, controlled clinical trials (> 2), including a significant number of patients (>100), with consistently positive conclusions for the indication.
Several randomized, double-blind, controlled clinical trials (> 2), including a significant number of patients (>100), with positive conclusions for the indication.
One or more randomized studies, or several cohorts or epidemiological studies, with positive conclusions for the indication.
Clinical studies exist but are uncontrolled, with conclusions that may be positive or conflicting.
No clinical studies to date that can demonstrate the indication.


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

Posologie

posologieOral

posologie100 IU


Properties


Gastroprotective

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

Usages associés

Helicobacter pylori infection


Safe dosage

Adult: 100 IU

Daily dose of 100 billion non-viable cells in two doses, after breakfast and dinner. nn1 IU = billions of CFU (Colony Forming Unit)nn