Bifilac (Bacillus clausii) for Viral Gastroenteritis in Children
Bifilac (Bacillus clausii) is not recommended for the treatment of viral gastroenteritis in children in North America, as there is insufficient high-quality evidence supporting its use. 1
Current Evidence on Probiotics for Viral Gastroenteritis
North American Evidence
The American Gastroenterological Association (AGA) specifically recommends against using probiotics for acute infectious gastroenteritis in children based on recent high-quality evidence from North America 1. Two large multicenter, randomized, double-blind, placebo-controlled trials conducted in the United States and Canada enrolled over 1,700 children and found no benefit of probiotics in treating acute gastroenteritis.
Regional Differences in Evidence
While some studies from other countries (particularly India, Italy, Poland, Turkey, and Pakistan) have shown benefits of certain probiotics for gastroenteritis, these results cannot be generalized to North American populations due to differences in:
- Host genetics
- Diet
- Sanitation
- Endemic enteropathogens
- Causes of acute infectious gastroenteritis 1
Evidence Specific to Bacillus clausii
Some research on Bacillus clausii preparations shows:
- A 2019 open-label study in Filipino children reported that B. clausii reduced diarrhea duration and stool frequency 2
- A 2025 meta-analysis found modest benefits with the Enterogermina® preparation of B. clausii (combination of O/C, SIN, N/R, and T strains) in reducing diarrhea duration, number of stools, and hospital stay 3
However, these studies:
- Were not conducted in North America
- Have methodological limitations
- Do not override the AGA's recommendation against probiotics for this indication
Standard of Care for Viral Gastroenteritis
For viral gastroenteritis in children, the following evidence-based approaches are recommended:
Rehydration Therapy
- Use reduced osmolarity oral rehydration solution (ORS) as first-line therapy for mild to moderate dehydration 4
- For severe dehydration, start with isotonic intravenous fluids at 60-100 mL/kg over 2-4 hours, then transition to ORS once the patient stabilizes 4
Nutrition
- Resume age-appropriate diet during or immediately after rehydration
- Offer food every 3-4 hours
- Avoid foods high in simple sugars and fats 4
Symptomatic Treatment
- Antimotility drugs (e.g., loperamide) should not be given to children under 18 years with acute diarrhea 4
- Ondansetron may be given to facilitate oral rehydration in children over 4 years with vomiting 4
- Zinc supplementation is beneficial for children 6 months to 5 years in areas with high prevalence of zinc deficiency 4
Prevention
- Proper hand hygiene and infection control measures are essential 4
- Rotavirus vaccination is recommended to prevent rotavirus gastroenteritis 1, 4
Common Pitfalls to Avoid
Assuming all probiotics are equivalent: Different probiotic strains have different effects, and evidence for one strain cannot be extrapolated to others.
Ignoring regional differences: Studies conducted outside North America may not be applicable to North American populations due to differences in diet, microbiome, and prevalent pathogens.
Using antimotility agents inappropriately: These should be avoided in children with acute diarrhea.
Neglecting rehydration: Proper rehydration remains the cornerstone of management for viral gastroenteritis.
Unnecessary antibiotic use: Antibiotics are not indicated for viral gastroenteritis and may worsen outcomes.
In conclusion, while some studies suggest potential benefits of Bacillus clausii in certain populations, the current high-quality evidence does not support its use for viral gastroenteritis in children in North America. Focus should remain on appropriate rehydration, nutrition, and supportive care.