Target intelligence / Profile preview

Alkalihalobacillus clausii

Molecular classification
Probiotic microorganism, Gram-positive bacterium, Spore-forming bacterium, Rod-shaped bacterium
01

Overview

Bacillus clausii (current correct nomenclature: Alkalihalobacillus clausii) is a Gram-positive, spore-forming, alkalitolerant rod-shaped bacterium naturally present in the soil and in the mammalian gastrointestinal tract[3][5]. It is used as a probiotic in formulations such as Enterogermina and Erceflora. Due to its unique resistance to gastric acid, bile salts, and many antibiotics, it survives ingestion and colonizes the gut, where it restores microbiota balance, inhibits pathogenic bacteria, and exerts immunomodulatory effects. Clinical studies have demonstrated its efficacy in reducing the duration and severity of acute pediatric diarrhea, antibiotic-associated diarrhea, and as adjunct therapy for Helicobacter pylori infections[2][4][6]. Bacillus clausii is generally well-tolerated but carries risk for bacteraemia/sepsis in immunocompromised individuals; regulatory agencies have issued warnings accordingly[3].

Other names
Bacillus clausiiB. clausii
02

Mechanism of action

Competes with pathogenic microorganisms for intestinal colonization. Modifies gut microbiota composition. Secretes antimicrobial substances antagonistic to pathogens (e.g., against Staphylococcus aureus, Clostridioides difficile). Modulates immune response by decreasing pro-inflammatory cytokines (e.g., TNF-α, IL-17, IL-23).

03

Biological functions

Restoration of intestinal microbiotaInhibition of pathogenic bacteria (production of antimicrobial substances)Immunomodulation (modulation of inflammatory cytokines)Resistance to stomach acid, bile, and heat
04

Disease associations

Gastrointestinal infections (e.g., acute diarrhea)Antibiotic-associated diarrheaHelicobacter pylori therapy adjunctUpper respiratory tract infectionsAllergic rhinitisNecrotizing enterocolitis and late-onset sepsis (prevention in neonates)Metabolic endotoxemia/intestinal permeability
05

Safety considerations

Risk of bacteraemia and sepsis, especially in immunocompromised patients (has led to regulatory warnings in Europe)Not recommended for patients with severely compromised immune systemsOtherwise generally well-tolerated in immunocompetent individuals
06

Interacting drugs

Antibiotics (co-administration)
07

Biomarkers

Reduction in serum or stool inflammatory cytokines (e.g., TNF-α, IL-17, IL-23, IL-1β, IL-12p70)Reduction of serum endotoxin during endotoxemia

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