Enterogermina

Enterogermina Mechanism of Action

bacillus clausii

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Action
Pharmacotherapeutic category: Anti-diarrheal microorganisms. ATC Code: A07FA.
Pharmacology: Pharmacodynamics: ENTEROGERMINA is a product consisting of a suspension of 4 strain (SIN, O/C, T, N/R) Bacillus clausii spores, which occur naturally in the intestine and are non-pathogenic.
When administered orally, the elevated resistance of Bacillus clausii spores to both chemical and physical agents allows them to cross the barrier of gastric juice, and to be unharmed when they reach the intestinal tract where they are transformed into metabolically active vegetative cells.
Spores can survive heat and gastric acidity, by nature. In a validated in vitro model Bacillus clausii spores demonstrated to survive in a simulated gastric environment (pH 1.4-1.5) until 120 minutes (survival rate of 96%). In a model that simulates the intestinal environment (saline solution of bile and pancreatin - pH 8), Bacillus clausii spores demonstrated their capability to multiply compared to the initial amount, in a statistically significant way (from 109 to 1012 CFU Colony-Forming Units), starting from 240 minutes after the incubation. In a study that was conducted on 20 individuals, it was noticed that, in humans, Bacillus clausii spores persist in the intestine and can be found in feces until 12 days after a single oral administration.
Because of the activity of Bacillus clausii, the administration of ENTEROGERMINA contributes to the restoration of intestinal microbial flora altered by dysmicrobism of varying origins, also known as dysbiosis, that results from the antibiotic therapy and that can be associated with gastrointestinal symptoms, e.g. diarrhea, abdominal pain and increase of air in the intestine.
In two open randomized controlled clinical trials, ENTEROGERMINA demonstrated to reduce the duration of acute diarrhea in children older than 6 months. When taken during the antibiotic treatment and the next 7-10 days, ENTEROGERMINA demonstrated to reduce the incidence of abdominal pain and diarrhea that are associated with the antibiotic treatment. The 2 main mechanisms, reported as follows, contribute to Bacillus clausii effect of restoring the intestinal bacterial flora.
Growth Inhibition of Pathogenic Bacteria: The three B. clausii supposed mechanisms of action are: colonization of free ecological niches, that are made unavailable by the growth of other microorganisms; competition for the bond with epithelial cells, that is particularly relevant for the spores in the germination initial and intermediate phases; production of antibiotics and/or enzymes that are secreted in the intestinal environment. In an in vitro study Bacillus clausii spores demonstrated to produce bacteriocins and antibiotics such as clausin, with antagonist activity against Gram-positive bacteria Staphylococcus aureus, Clostridium difficile, Enterococcus faecium.
Immunomodulatory activity: Bacillus clausii spores, administered through the oral route, in in vitro and in vivo murine models demonstrated to stimulate the production of Interferon-gamma and to increase the CD4+ T Lymphocyte proliferation.
As Bacillus clausii is also capable of producing various vitamins, especially B vitamins, ENTEROGERMINA aids in correcting avitaminosis due to antibiotics and chemotherapy in general. ENTEROGERMINA produces an aspecific antigenic and antitoxic effect, closely connected with the metabolic action of Bacillus clausii.
The high level of artificially induced heterologous resistance to antibiotics creates the therapeutic conditions for preventing the alteration of microbial intestinal flora by the selective action of antibiotics, particularly broad-spectrum antibiotics, or for restoring them.
Due to its antibiotic resistance, ENTEROGERMINA may be administered between two subsequent administrations of antibiotics.
Antibiotic resistance refers to: penicillins, if not in combination with beta-lactamase inhibitors, cephalosporins (partial resistance in most cases), tetracyclines, macrolides, aminoglycosides (except for gentamicin and amikacin), chloramphenicol, thiamphenicol, lincomycin, clindamycin, isoniazid, cycloserine, novobiocin, rifampicin, nalidixic acid and pipemidic acid (intermediate resistance), and metronidazole.
Pharmacokinetics: Absorption and elimination: ENTEROGERMINA is not absorbed from the gastrointestinal tract. In animals, low numbers of B. clausii cells were found in mesenteric ganglia after administration of large doses of ENTEROGERMINA but no cells were found in the blood or spleen.
No intrinsic factor (age, sex, race, genetic polymorphism, renal or hepatic impairment) is likely to influence the fate of ENTEROGERMINA in the organism.
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