What is the recommended dose of Sporlac (Bacillus clausii) for an adult and for a child, and how should it be administered via a nasogastric tube?

Sporlac (Bacillus clausii) Dosing Recommendations

For adults, administer Bacillus clausii at 6 × 10⁹ CFU/day (typically 3 vials of 2 billion CFU each), and for children, use 4 × 10⁹ CFU/day (typically 2 vials of 2 billion CFU each), administered for up to 14 days during antibiotic therapy or for gastrointestinal symptoms. 1

Standard Dosing by Age Group

Adults and Adolescents

• 6 × 10⁹ CFU per day is the evidence-based dose for preventing antibiotic-associated diarrhea and managing gastrointestinal symptoms 1
• This typically translates to 3 vials daily if using standard 2 billion CFU formulations
• Treatment duration: up to 14 days 1

Children (6-17 years)

• 4 × 10⁹ CFU per day for antibiotic-associated diarrhea prevention 1
• This typically translates to 2 vials daily if using standard 2 billion CFU formulations
• Treatment duration: up to 14 days 1

Young Children with Persistent Diarrhea

• For more severe persistent diarrhea, higher dosages of 4-6 ampoules per day (8-12 × 10⁹ CFU/day) have demonstrated significant efficacy 2
• This high-dose regimen achieved 2-day shorter recovery periods and 3 days faster overall recovery from diarrhea disease 2
• The higher dose showed 1.5-1.6 fold greater efficacy in reducing diarrhea symptoms including high stool frequency, fecal mucus, and abnormal stool consistency 2

Administration via Nasogastric Tube

• Bacillus clausii can be administered via nasogastric (NG) tube, as demonstrated in critical care settings where probiotics were given through NG tubes 3
• Mix the liquid suspension or dissolved contents with water (typically 20-30 mL) to ensure easy passage through the tube
• Flush the NG tube with 10-20 mL of water before and after administration to prevent clogging
• Administer at room temperature; no special preparation required beyond standard NG tube medication protocols

Clinical Efficacy and Mechanisms

• Bacillus clausii significantly reduces the risk of antibiotic-associated diarrhea and associated gastrointestinal symptoms including nausea and epigastric pain 1
• The probiotic demonstrates immunomodulatory effects, with significant decreases in pro-inflammatory cytokines (TNF-α by 3.24%, IL-17 by 29.76%, IL-23 by 10.87%) at day 5 of treatment 2
• Spore-forming nature makes B. clausii resistant to gastric acid and most commonly used antibiotics, allowing survival through the gastrointestinal tract 1, 4

Important Clinical Considerations

• Timing with antibiotics: Can be administered concurrently with antibiotic therapy due to antibiotic resistance of the spores 1, 4
• Safety profile: Significant adverse effects are rare, with no known medication interactions 5
• Duration: While 14 days is the studied duration for antibiotic-associated diarrhea prevention, treatment for persistent diarrhea may require the full course until symptom resolution 1, 2

Formulation Notes

• Standard formulations typically contain 2 billion CFU per 5 mL ampoule 2
• The four-strain formulation (O/C, N/R, SIN, T) is the most commonly studied and recommended 1, 4, 6
• Liquid suspension form is preferred for NG tube administration and pediatric use 2