ENTEROGERMINA® 4 BILLION

Bacillus clausii Oral Suspension – Probiotic Dietary Supplement

Composition
Each 5 mL mini-vial contains 4 billion spores of poly-antibiotic-resistant Bacillus clausii, strains SIN, O/C, T, and N/R, in purified water, according to the product information shown on the package.

Medical Description

Enterogermina® 4 Billion is an oral probiotic suspension containing spore-forming strains of Bacillus clausii. Probiotics are live microorganisms that may provide a health benefit when administered in adequate amounts. Their effects are generally strain-specific, meaning that evidence for one probiotic strain cannot automatically be applied to another.

The Bacillus clausii spores are designed to survive passage through the gastrointestinal tract and may contribute to maintaining or restoring the balance of intestinal microorganisms. The product is therefore used as a dietary probiotic supplement to support intestinal microbial balance, particularly when the normal intestinal microbiota may be disturbed.

Potential Benefits

• Supports intestinal microbiota balance by providing viable probiotic microorganisms.
• May support normal gastrointestinal function during temporary disturbances of the intestinal microbiota.
• Bacillus clausii has been studied as an adjunctive probiotic in diarrheal disorders; however, clinical benefits vary according to the specific strain, dose, patient population, and clinical condition.
• Probiotic supplementation may have a role as an adjunct, rather than a replacement, for established management of acute diarrhea.

Important Note Regarding Diarrhea

Enterogermina should not be considered a replacement for oral rehydration therapy when diarrhea is present. The World Health Organization recommends oral rehydration solution (ORS), continued feeding, and appropriate zinc supplementation in children with acute diarrhea. Medical evaluation is particularly important when diarrhea is persistent, bloody, or accompanied by signs of dehydration.

Evidence regarding Bacillus clausii is not completely consistent. The 2023 ESPGHAN position paper specifically concluded that the available evidence was insufficient to recommend B. clausii strains O/C, SIN, N/R, and T for treatment of acute gastroenteritis in children. Therefore, claims that Enterogermina will definitely treat or shorten diarrhea should be avoided.

Suggested Use

According to the product label shown:

• Adults: 1 mini-vial daily.
• Children and breast-feeding infants: 1 mini-vial daily.
• The contents may be taken directly or diluted in water or another beverage.
• For oral use only; do not inject or administer by another route.

Follow the product label or the advice of a physician/pharmacist, particularly when using the product in infants or young children.

Storage

• Store below 30°C, protected from light and out of the reach of children.
• Once a mini-vial is opened, use it within a short period according to the manufacturer's instructions to minimize contamination.

Precautions & Warnings

Although probiotics are generally well tolerated in healthy individuals, they are not appropriate for everyone. NIH guidance notes that serious infections associated with probiotics have been reported particularly in people who are severely ill or immunocompromised.

Consult a healthcare professional before use in:

• People with significantly weakened immune systems.
• Critically or severely ill patients.
• Patients with serious underlying medical conditions.
• Premature or medically fragile infants.
• Infants or children with significant dehydration, persistent vomiting, bloody diarrhea, high fever, or severe abdominal pain.

Mild gastrointestinal symptoms such as gas or abdominal discomfort may occur with probiotics.

Patient Disclaimer

This product is a dietary supplement and is not intended to diagnose, treat, cure, or prevent any disease. Enterogermina® should not replace prescribed medical treatment, oral rehydration therapy, appropriate nutrition, or medical evaluation when clinically indicated. Individual responses to probiotics may vary, and the evidence for benefits is specific to the probiotic strain and clinical condition. If diarrhea is severe or persistent, contains blood, or is associated with dehydration, fever, repeated vomiting, or deterioration—especially in infants and children—seek medical attention promptly. Always consult your physician or pharmacist before use if you have a medical condition, weakened immunity, or concerns regarding use in an infant or child.

References

1. World Health Organization (WHO) – Diarrhoeal Disease.
2. World Health Organization (WHO) – Clinical Management of Acute Diarrhoea: WHO/UNICEF Joint Statement.
3. World Health Organization (WHO) – Zinc Supplementation in the Management of Diarrhoea.
4. NIH Office of Dietary Supplements (ODS) – Probiotics: Fact Sheet for Consumers.
5. NIH Office of Dietary Supplements (ODS) – Probiotics: Health Professional Fact Sheet.
6. ESPGHAN – Probiotics for the Management of Pediatric Gastrointestinal Disorders: Position Paper, 2023.
7. World Gastroenterology Organisation (WGO) – Acute Diarrhea Guidelines.
8. Enterogermina® 4 Billion Patient Information Leaflet – product composition and directions.