When should Enterogermina (Bacillus clausii) be administered to an infant (>1 month) with acute or antibiotic-associated diarrhoea or suspected gut flora disturbance?

When to Give Enterogermina to an Infant

Do not routinely give Enterogermina (Bacillus clausii) to infants with acute gastroenteritis in North America, as current AGA guidelines recommend against probiotics for this indication based on high-quality North American trials showing no benefit. 1

Geographic and Evidence Considerations

The 2020 AGA guidelines explicitly recommend against the use of probiotics for acute infectious gastroenteritis in children, based on four large North American randomized controlled trials (enrolling 943 and 827 children) that showed no benefit for moderate-to-severe gastroenteritis. 1 The guidelines emphasize that differences in host genetics, diet, sanitation, and endemic pathogens between North America and other global regions mean that positive studies from India, Italy, Poland, Turkey, and Pakistan cannot be generalized to North American populations. 1

Limited Evidence for Bacillus clausii Specifically

• While a 2025 meta-analysis of Enterogermina showed modest reductions in diarrhea duration (0.6 Hedge's g), number of stools (0.34 Hedge's g), and hospital stay (0.27 Hedge's g), these studies were predominantly conducted outside North America and had fair-to-good risk of bias. 2
• A 2022 Indian randomized controlled trial of Bacillus clausii plus ORS and zinc versus placebo plus ORS and zinc showed no statistically significant difference in time to recovery (42.83 vs 42.13 hours, p=0.6968), likely because ORS and zinc were highly effective in both groups. 3

Specific Clinical Scenarios Where Enterogermina Should NOT Be Used

Contraindications and High-Risk Situations

• Never use in malnourished infants or those with severe diarrhea causing intestinal epithelial damage, as these conditions predispose to bacteremia and sepsis from probiotic translocation. 4
• Never use in immunocompromised infants, including those with protein-calorie malnutrition, as a fatal case of Bacillus clausii septicemia occurred in a 4-month-old malnourished infant who received Enterogermina for acute diarrhea with moderate-severe dehydration. 4
• Never use in infants with severe dehydration (≥10% fluid deficit), as these patients require immediate IV rehydration, not probiotics. 5

The Only Evidence-Based Probiotic Indication in Infants

The sole strong recommendation for probiotics in infants is for preterm, low-birth-weight neonates (<37 weeks gestational age) to prevent necrotizing enterocolitis and mortality, using specific combinations of Lactobacillus and Bifidobacterium species—not Bacillus clausii. 1

Correct Management Algorithm for Infant Acute Gastroenteritis

Assessment (First 5 Minutes)

• Classify dehydration severity: mild (3-5%), moderate (6-9%), or severe (≥10%) based on skin turgor, capillary refill, mental status, mucous membrane moisture, and breathing pattern. 5
• Check for red flags: bloody stools with fever (bacterial dysentery), bilious vomiting (obstruction), absent bowel sounds (ileus), or altered mental status (severe dehydration). 5

Treatment Based on Dehydration Severity

• Mild dehydration: Give 50 mL/kg oral rehydration solution (ORS) over 2-4 hours using 5-10 mL every 1-2 minutes via spoon or syringe. 5
• Moderate dehydration: Give 100 mL/kg ORS over 2-4 hours using the same small-volume technique. 5
• Severe dehydration: Immediate IV boluses of 20 mL/kg lactated Ringer's or normal saline, repeated until pulse, perfusion, and mental status normalize; this is a medical emergency requiring hospitalization. 5

Nutritional Management

• Resume age-appropriate normal diet immediately during or after rehydration; continue breastfeeding throughout. 5
• Avoid soft drinks, undiluted apple juice, high-fat foods, and caffeinated beverages. 5

When Antibiotics Are Indicated (Not Probiotics)

• Consider antibiotics only for: bloody diarrhea with high fever and systemic toxicity, watery diarrhea persisting >5 days, positive stool culture for treatable bacterial pathogen, or immunocompromised host. 5

Critical Pitfalls to Avoid

• Do not delay ORS administration while considering probiotic therapy—rehydration is the cornerstone of treatment and should begin immediately. 5
• Do not use Enterogermina as a substitute for proper fluid and nutritional therapy, as reliance on probiotics shifts focus away from evidence-based management. 5
• Do not use antimotility agents (loperamide) in any infant or child <18 years, as serious adverse events including ileus and death have been reported. 6