Probiotics in Pediatrics: Age-Specific Guidelines
Based on the most recent high-quality guidelines, probiotic use in pediatrics is highly age-dependent, with the strongest evidence supporting specific strain combinations in preterm neonates for preventing necrotizing enterocolitis and mortality, while use in older children should be limited to specific gastrointestinal conditions with well-studied strains only. 1
Preterm Neonates (<37 weeks gestational age, low birth weight)
Recommended Strains and Combinations
For preterm infants, use combination therapy with Lactobacillus rhamnosus ATCC 53103 plus Bifidobacterium longum subspecies infantis, or single-strain Bifidobacterium animalis subspecies lactis DSM 15954 to prevent necrotizing enterocolitis (NEC), sepsis, and all-cause mortality. 1, 2, 3
- B. animalis subsp. lactis reduces all-cause mortality (OR 0.56,95% CI 0.39-0.80) and severe NEC (OR 0.31,95% CI 0.13-0.74) with moderate-to-high quality evidence 3
- B. animalis subsp. lactis significantly reduces hospitalization days by 13 days (95% CI -22.71 to -3.29) with high certainty 3
- Combination products containing L. rhamnosus ATCC 53103 with Bifidobacterium species reduce severe NEC compared to placebo 2
- Alternative acceptable combinations include: L. acidophilus with B. bifidum, or L. acidophilus with B. longum subsp. infantis 1
Critical Safety Considerations for Preterm Neonates
- Prioritize pharmaceutical-grade products over dietary supplements as manufacturing contaminants have caused fatal infections in preterm infants 2, 3
- Probiotics do not increase sepsis risk based on evidence from >10,000 preterm infants 3
- Exercise extreme caution or avoid use in immunocompromised infants, critically ill patients with indwelling central venous catheters, infants with cardiac valvular disease, and infants with short-gut syndrome 1, 2, 3
Evidence Quality Note
The evidence for preterm neonates is robust, with meta-analyses showing enteral probiotic supplementation significantly reduces any sepsis (RR 0.83,95% CI 0.73-0.94), bacterial sepsis (RR 0.82,95% CI 0.71-0.95), and fungal sepsis (RR 0.57,95% CI 0.41-0.78) 1. However, this beneficial effect remains in very low birth weight infants (<1500g) but not in extremely low birth weight infants (<1000g) 1.
Term Infants (0-12 months)
Infantile Colic (Breastfed Infants)
Use Lactobacillus reuteri DSM 17938 specifically for breastfed babies with infantile colic. 1, 4
- This is the only probiotic strain with strong evidence for colic treatment 1
- Evidence is less supportive for formula-fed infants 1
Acute Gastroenteritis in North American Infants
Do not use probiotics for acute gastroenteritis in infants and children in North America. 1
- Two large multicenter RCTs (943 and 827 children) from the Pediatric Emergency Care Applied Research Network and Pediatric Emergency Research Canada showed no benefit 1
- L. rhamnosus ATCC 53103 and combination L. rhamnosus R0011 with L. helveticus R0052 both failed to show benefit 1
- Studies from other global regions (India, Italy, Poland, Turkey, Pakistan) cannot be generalized to North American populations due to differences in host genetics, diet, sanitation, and endemic enteropathogens 1
Children and Adolescents (1-18 years)
Conditions with Evidence-Based Recommendations
For prevention of nosocomial diarrhea: Use Lactobacillus rhamnosus GG (LGG) at doses >10^9 CFU/day 1
For prevention of antibiotic-associated diarrhea: Use either Saccharomyces boulardii CNCM I-745 or LGG 1
- Meta-analysis shows probiotics at 5-40 × 10^9 CFUs daily (L. GG, L. sporogens, or S. boulardii) reduce antibiotic-associated diarrhea (RR 0.36,95% CI 0.25-0.53) 5
For adjunct treatment of acute gastroenteritis (outside North America): Consider Saccharomyces boulardii CNCM I-745, LGG, or L. reuteri DSM 17938 1
- Note: ESPGHAN updated recommendations in 2018 after two large RCTs questioned probiotic efficacy 1
Conditions WITHOUT Supportive Evidence
Do not use probiotics for:
Post-Traumatic/ICU Settings (Pediatric and Adult)
- Probiotics reduce nosocomial infections (RR 0.65,95% CI 0.45-0.94), ventilator-associated pneumonia (RR 0.59,95% CI 0.42-0.81), and ICU length of stay 1
- No mortality benefit demonstrated (RR 0.63,95% CI 0.32-1.26) 1
Universal Safety Precautions Across All Ages
High-Risk Populations Requiring Caution
Exercise extreme caution or avoid probiotics in: 1, 6
- Premature neonates (context-dependent; see preterm section above)
- Immunocompromised patients
- Critically ill patients with central venous catheters
- Patients with cardiac valvular disease
- Patients with short-gut syndrome
- Patients with damaged intestinal mucosa
Product Quality Considerations
- Always verify the precise bacterial identity at the strain level when selecting a probiotic 6
- Consider products deposited at biodepositories such as the American Type Culture Collection (ATCC) for quality assurance 6
- The amount of dead bacteria in a preparation is inversely proportional to product quality 6
- Avoid products with extremely high concentrations (450-900 billion bacteria per dose) as safety becomes more sensitive 6
Taxonomic Update (2020)
Be aware that Lactobacillus genus was reclassified in 2020: 1
- Lactobacillus rhamnosus → Lacticaseibacillus rhamnosus
- Lactobacillus reuteri → Limosilactobacillus reuteri
Key Clinical Pitfalls to Avoid
- Do not assume all probiotics are equivalent - effects are highly strain-specific and dose-specific 7, 8, 4
- Do not extrapolate evidence from one geographic region to another - particularly for acute gastroenteritis where North American studies contradict international findings 1
- Do not use probiotics in predicted severe acute pancreatitis - multispecies preparations associated with increased mortality 6
- Do not rely on dietary supplement-grade products for preterm neonates - pharmaceutical-grade products essential to prevent contamination-related deaths 2, 3
- Do not use Saccharomyces boulardii in critically ill or immunocompromised patients - associated with fungemia risk 6