1. Beal, Judy A. DNSc, RN, FAAN

Article Content

Approximately 10% of extremely low gestational age babies receive probiotics in the neonatal intensive care unit (NICU) and thousands have been enrolled in clinical trials of probiotic administration, despite recent research calling for caution for routine probiotic use in preterm infants (Chi et al., 2021; Poindexter et al., 2021). The American Academy of Pediatrics (AAP) issued an advisory statement in 2010 followed by that of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition in 2018, the Canadian Pediatric Society in 2019, the American Gastroenterological Association in 2020, and the AAP again in 2021 (Poindexter et al.; Wycoff, 2021). There is a lack of evidence and subsequent warnings, yet use of probiotics in this vulnerable population is on the increase around the world.


Probiotics are considered dietary supplements that can alter the microflora of the gut and therefore have beneficial effects for healthy humans. Probiotics, however, have not been approved by the United States Food and Drug Administration (FDA) for prevention or treatment of disease in preterm infants. Although there was a modest amount of early evidence that probiotics may be effective in treating acute viral gastroenteritis and preventing antibiotic-associated diarrhea in healthy infants and even in preventing necrotizing enterocolitis (NEC) in very low birthweight infants, the evidence remains confusing and conflicting (Thomas et al., 2010).


Poindexter et al. (2021) conducted a meta-analysis on the role of the intestinal microbiome as a marker of disease in preterm infants; types of probiotic preparations; proposed benefits of probiotics for health and preterm infants; potential adverse effects; and efficacy to prevent NEC and sepsis in preterm infants. Findings revealed several methodological differences in study protocols including use of different strains of probiotics, different combination of protocols, masking of therapies, and inconsistent definitions of outcomes and terms, that raised significant concern. Therefore, in 2021, AAP reissued a strong warning that due to lack of evidence on effectiveness and long-term safety as well as the unavailability of an FDA-approved pharmaceutical-grade probiotic, "probiotics should not be routinely given to preterm infants, especially those weighing less than 1,000 grams" (Wycoff, 2021, p. 1).


Pediatric nurses working in the NICU need to be aware of these warnings and should raise questions about routine protocols for probiotic administration. Although we await further research on safety and efficacy, providers must discuss with parents the risks and benefits of probiotic treatment and should consider implementation of an informed consent process. Introduction of probiotics into a NICU has been shown to alter the unit's flora and potentially adversely affect all patients. Documentation of administration and outcomes is therefore critical (Wycoff, 2021).


Although the use of probiotics with very low birthweight premature infants is not warranted, research has shown that for healthy infants, breast milk has a significant amount of naturally occurring probiotic bacteria and use of probiotics may decease diarrhea from viral-induced illness by one day (Thomas et al., 2010). Until the evidence becomes more definitive, pediatric providers must continue to monitor the evidence and advise parents appropriately.




Chi C., Li C., Buys N., Wang W., Yin C., Sun J. (2021). Effects of probiotics in preterm infants: A network meta-analysis. Pediatrics, 147(1), e20200706.[Context Link]


Poindexter B.American Academy of Pediatrics Committee on Fetus and Newborn. (2021). Use of probiotics in preterm infants. Pediatrics,147(6), e2021051485.[Context Link]


Thomas D. W., Greer F. R.American Academy of Pediatrics Committee on Nutrition, Section on Gastroenterology, Hepatology, and Nutrition. (2010). Probiotics and prebiotics in pediatrics. Pediatrics, 126(6), 1217-1231.[Context Link]


Wycoff A. S. (2021). Evidence does not support routine probiotic use in preterm infants. AAP clinical report. AAP News. Itasca, IL: American Academy of Pediatrics.[Context Link]