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Use of Probiotics in Preterm Infants
1Children's Healthcare of Atlanta and School of Medicine, Emory University, Atlanta, Georgia brenda.poindexter@emory.edu.
Insights
Current probiotics for preterm infants lack FDA approval and rigorous standards. While some studies show benefits, evidence does not support routine use due to safety and efficacy concerns.
Area of Science:
- Neonatal Medicine
- Microbiology
- Pharmacology
Background:
- Probiotics are often sold as dietary supplements in the U.S., bypassing strict FDA drug approval for safety and efficacy.
- This regulatory gap means probiotics cannot be marketed for disease prevention or treatment in vulnerable populations like preterm infants.
Purpose of the Study:
- To evaluate the current evidence supporting probiotic use in preterm infants.
- To assess the safety and efficacy of available probiotic products for neonatal care.
Main Methods:
- Review of randomized clinical trials and meta-analyses on probiotic supplementation in preterm infants worldwide.
- Analysis of regulatory status and product quality of probiotics available in the United States and Canada.
Main Results:
- Meta-analyses suggest multi-strain probiotics may reduce necrotizing enterocolitis and mortality.
- Efficacy of single-strain probiotics is less clear.
- Many preterm infants receive non-pharmaceutical grade probiotics, some with contamination issues.
Conclusions:
- Lack of FDA-regulated, medical-grade probiotics in the U.S. raises safety concerns.
- Conflicting data on safety and efficacy, coupled with potential harm, preclude routine universal probiotic administration in preterm infants.
- Special caution is advised for extremely low birth weight infants (<1000 g).
Abstract:
Probiotic products in the United States are available for use in the general category of dietary supplements, bypassing the rigor of the US Food and Drug Administration (FDA) approval process in safety, efficacy, and manufacturing standards. As a result, currently available probiotics lack FDA-approved drug labeling and cannot be marketed to treat or prevent disease in preterm infants, including necrotizing enterocolitis and late-onset sepsis. Despite lack of availability of a pharmaceutical-grade product, the number of preterm infants receiving probiotics in the United States and Canada is steadily increasing. According to recent reports from large collaborative databases in the United States, approximately 10% of extremely low gestational age neonates receive a probiotic preparation during their stay in the NICU, with wide variation in practice among units. In sum, more than 10 000 preterm infants have been enrolled in randomized clinical trials of probiotic supplementation worldwide. Methodologic differences among study protocols included different strains and combinations of therapy, masking of trials, and a priori definitions of the primary outcome measure. Large meta-analyses of these trials have demonstrated the efficacy of multiple-strain probiotics in reducing necrotizing enterocolitis and all-cause mortality, whereas the efficacy of single-strain probiotic preparations is less certain. In the absence of an appropriate medical-grade product in the United States, dietary supplement-grade probiotics, some of which have been the subject of recent recalls for contamination, are being prescribed. Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of <1000 g.
