Bacillus Clausii spores

Approved Indications:

• Acute Diarrhea: Treatment of infectious or non-infectious acute diarrhea in children and adults.
• Antibiotic-Associated Diarrhea (AAD): Prevention and treatment of diarrhea caused by alteration of intestinal flora due to antibiotic use.
• Chronic Diarrhea: Management of chronic or recurrent diarrhea of unexplained origin.
• Diarrhea in Infants and Children: Including dietary errors and viral gastroenteritis.

Clinically Accepted Off-Label Uses:

• Adjunct in Helicobacter pylori Eradication Therapy: Used alongside triple or quadruple regimens to reduce gastrointestinal side effects and restore gut flora.
• Diarrhea in Immunocompromised Individuals: Used with caution under medical supervision.
• Functional Gastrointestinal Disorders: Such as bloating, flatulence, indigestion, and irritable bowel syndrome (IBS).
• Small Intestinal Bacterial Overgrowth (SIBO): Supportive role in managing dysbiosis.

Route of Administration: Oral
Formulations: Capsules (2 billion spores), Oral suspension vials (5 mL containing 2 billion spores)

Adults:

• Capsule: 1–2 capsules daily in divided doses
• Suspension: 5 mL once or twice daily

Children (2–12 years):

• Suspension: 5 mL once or twice daily

Infants (<2 years):

• Suspension: 5 mL once daily, preferably after feeding

Elderly:

• No routine dose adjustment required

Special Populations:

• Renal Impairment: No dose modification necessary
• Hepatic Impairment: No adjustment needed
• During Antibiotic Use: Administer Bacillus Clausii 2–3 hours after antibiotics to prevent inactivation

Administration Instructions:

• Shake the vial well before use
• Do not mix with hot or carbonated drinks
• Best taken after meals
• Continue full course even if symptoms improve

Bacillus Clausii is a gram-positive, aerobic, spore-forming probiotic bacterium that acts by restoring the balance of the intestinal microbiota. Its spores are resistant to gastric acid, allowing survival through the stomach. Once in the intestine, the spores germinate into active cells that colonize the gut, competitively inhibit pathogenic bacteria, and produce antimicrobial substances. Bacillus Clausii also modulates immune responses, enhances gut barrier function, and aids in nutrient metabolism. Its intrinsic resistance to a broad spectrum of antibiotics allows it to maintain probiotic action during antibiotic therapy.

• Absorption: Not systemically absorbed; remains within the gastrointestinal tract
• Distribution: Localized action in the intestinal lumen
• Metabolism: Does not undergo hepatic metabolism; metabolically active in the gut only
• Excretion: Spores and vegetative forms are eliminated via feces
• Bioavailability: Confined to the gut lumen; not bioavailable in systemic circulation
• Onset of Action: Within 12–24 hours of initial dose
• Duration of Colonization: May persist in the gut for up to 7 days post-treatment

Pregnancy:

• FDA Category: Not officially classified
• Clinical Summary: Considered safe in pregnancy due to non-systemic absorption. Use with caution in pregnant women with compromised immunity.

Lactation:

• Not excreted into breast milk
• No known adverse effects in nursing infants
• Considered safe for use during breastfeeding

Caution: Avoid use in newborns and premature infants unless under strict medical supervision

• Primary Class: Probiotic
• Subclassification: Spore-forming probiotic bacterium
• Strains Commonly Included: Bacillus Clausii strains SIN, T, N/R, and O

• Known hypersensitivity to Bacillus Clausii or any component of the formulation
• Severely immunocompromised states (e.g., hematological malignancy, transplant recipients)
• Critically ill patients with central venous catheters
• Premature or very low birth weight infants (without medical supervision)

• Severely immunocompromised individuals may be at risk for systemic infections; use only under physician supervision
• Not a substitute for antibiotics in active bacterial infections
• Monitor stool patterns during use; discontinue if diarrhea worsens
• Avoid combining with hot or alcoholic beverages
• Do not use beyond recommended duration without re-evaluation
• Observe for allergic reactions, especially in children

Common (Usually Mild):

• Gastrointestinal: Flatulence, bloating, soft stools
• Mild abdominal discomfort

Rare but Serious:

• Hypersensitivity reactions (rash, itching, urticaria)
• Rare cases of bacteremia or sepsis in immunocompromised patients

Onset: Usually within the first 1–3 days of therapy
Severity: Mild and transient; dose-independent in most patients

• Antibiotics: May reduce probiotic efficacy if taken simultaneously. Separate doses by 2–3 hours
• Alcohol: Can deactivate spores and reduce probiotic action; avoid concurrent use
• Immunosuppressants: Use with caution due to potential for systemic spread

Enzymatic Interactions:

• No known interaction with CYP450 enzyme systems
• No systemic pharmacokinetic interactions reported

• Clinical guidelines from pediatric and gastroenterology bodies recommend Bacillus Clausii as an adjunctive therapy for AAD
• Ongoing trials are exploring its potential role in irritable bowel syndrome and inflammatory bowel diseases
• Recent safety reviews reaffirm low risk of adverse events in immunocompetent patients
• Manufacturers are exploring new combination probiotic formulations including Bacillus Clausii for broader gut microbiota support

• Temperature: Store between 20°C to 30°C
• Light Protection: Store in original packaging away from direct light
• Humidity: Keep in a dry environment
• Freezing: Do not freeze
• Reconstitution: Not required for pre-filled vials
• Handling:
• Shake well before use (oral suspension)
• Use immediately after opening
• Keep out of reach of children