ENTEROGERMINA ® Bacillus Clausii spores

ENTEROGERMINA ® is a drug based on polyantibiotic resistant Bacillus Cluasii spores

THERAPEUTIC GROUP: Antidiarrheal - Antidiarrheal microorganisms.

Indications ENTEROGERMINA ® Bacillus Clausii spores

ENTEROGERMINA ® is a medicine used in the prophylaxis and treatment of intestinal dysmicrobism. The efficacy of ENTEROGERMINA ® in restoring the correct bacterial flora also makes it useful during antibiotic therapies or gastro-enteric pathologies of infectious origin with associated symptoms.

Mechanism of action ENTEROGERMINA ® Bacillus Clausii spores

The microorganisms contained in ENTEROGERMINA ® are part of the common constitution of the intestinal bacterial flora. The spore form, particularly resistant to environmental adversities, allows Bacillus Clausii to overcome the gastric acid environment unscathed, reaching the intestinal lumen, where thanks to a favorable environment it can re-originate the vegetative form.
The benefits of ENTEROGERMINA ® in terms of restoring the resident bacterial flora are guaranteed both by the ability to form new viable colonies, rebalancing the present population, and by the ability to increase the production of B vitamins and active metabolites useful for supporting the vitality of the intestinal mucosa. At the same time, ENTEROGERMINA ® exerts a "bactericidal action against" any pathogenic component, both indirect (competition for adhesion sites to the intestinal mucosa) and direct (secretion of active substances with direct or indirect bactericidal action).
Furthermore, the polyantibiotic resistance allows B. Clausii to be used successfully even during antibiotic therapy, without being affected by the cytotoxic effects induced by the drug.
The antidiarrheal action of ENTEROGERMINA ®, on the other hand, seems to take place both through the bactericidal action against pathogens and through the ability of its metabolites to restore the integrity of the intestinal mucosa.

Studies carried out and clinical efficacy

BACILLUS CLAUSII DURING THE ERADICATION TREATMENT OF H. PYLORI

Aliment Pharmacol Ther. 2004 Nov 15; 20: 1181-8.

Bacillus clausii therapy to reduce side-effects of anti-Helicobacter pylori treatment: randomized, double-blind, placebo controlled trial.

Nista EC, Candelli M, Cremonini F, Cazzato IA, Zocco MA, Franceschi F, Cammarota G, Gasbarrini G, Gasbarrini A.

The eradication of H. Pylori requires an important antibiotic therapy, which in most cases is accompanied by the onset of side effects - such as nausea, diarrhea and abdominal pain - partly responsible for the discontinuation of therapy. The concomitant intake of B. Clausii seems to be able to effectively reduce this annoying symptomatology, also improving the response to antibiotic therapy.

2. ENTEROGERMINE AND IMMUNOMODULATION

Eur Ann Allergy Clin Immunol. 2005 Apr; 37: 129-34.

Bacillus clausii exerts immuno-modulatory activity in allergic subjects: a pilot study.

Ciprandi G, Vizzaccaro A, Cirillo I, Tosca MA.

It is well known that the intestine represents a very important immune organ, so changes in its state of health can affect the patient's overall immunological condition. This Italian study, in fact, shows how the prolonged administration of B.Clausii spores can change the immunological picture in allergic individuals, guaranteeing an "immunomodulatory and regulatory action.

3.BACILLUS CLAUSII NOT ONLY A PROBIOTIC

Eur J Gastroenterol Hepatol. 2005 Sep; 17: 951-60.

Bacillus clausii effect on gene expression pattern in small bowel mucosa using DNA microarray analysis.

Di Caro S, Tao H, Grillo A, Franceschi F, Elia C, Zocco MA, Gasbarrini G, Sepulveda AR, Gasbarrini A.

Experimental evidence suggests that the activity of B. Clausii is not only linked to its probiotic action, but also to various other molecular mechanisms yet to be clarified. An in vitro study has indeed observed how this microorganism, in contact with intestinal mucosal cells, can guarantee a modulation of gene expression and precisely of about 158 ​​genes. These mechanisms could underlie the direct effects on the intestinal mucosa.

Method of use and dosage

ENTEROGERMINA ® 2 billion spore vial or capsules of polyantibiotic resistant Bacillus Clausii: it is recommended to take two / three capsules or vials per day taken at regular intervals of 4 hours, until symptoms improve. The vials can be diluted in the beverage of your choice.
The dosage for children should be quantitatively halved compared to the adult.

Warnings ENTEROGERMINA ® Bacillus Clausii spores

There are no particular precautions regarding the use of ENTEROGERMINA ®
The high safety profile and the absence of a systemic absorption with relative metabolism, allows its use also in patients suffering from liver and kidney diseases.
The presence of corpuscles in the contents of the vial is not necessarily a sign of sophistication of the product, but must be traced back (when the conservation rules are respected) to the presence of aggregates of spores; therefore, it should be shaken before taking the medicine.
ENTEROGERMINA ® absolutely does not alter the normal ability to drive or use machinery.

PREGNANCY AND BREASTFEEDING

ENTEROGERMINA ® is safe and well tolerated even when taken during pregnancy.
Despite the excellent safety profile, it would still be advisable and preferable to warn your doctor before taking any type of medicine.

Interactions

No clinically relevant interactions are currently known between ENTEROGERMINA ® and other active ingredients.
The polyantibiotic resistance allows its use even during antibiotic and pharmacological therapy in general (in this case it would be useful to take ENTEROGERMINA ® between the administration of antibiotics).

Contraindications ENTEROGERMINA ® Bacillus Clausii spores

ENTEROGERMINA ® is contraindicated in patients with known hypersensitivity to one of its components

Undesirable Effects - Side Effects

The scientific literature seems to be quite in agreement in considering the administration of ENTEROGERMINA ® to be safe and well tolerated given the absence of clinically relevant side effects.
However, the post-marketing experience shows, in rare cases, the onset of flatulence and abdominal pain following the chronic intake of probiotic drugs.

Note

ENTEROGERMINA ® is an OTC drug, without the obligation of a doctor's prescription, therefore it can be sold freely.

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