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Cited by 171Infant Nutrition and HealthProbiotics and Fermented FoodsNeonatal and Maternal Infections

Use of Probiotics in Preterm Infants

Poindexter, Brenda, COMMITTEE ON FETUS AND NEWBORN, Cummings, James, Hand, Ivan, Adams-Chapman, Ira, Aucott, Susan W., Puopolo, Karen M., Goldsmith, Jay P. +3 more·2021·Pediatrics
DOI 10.1542/peds.2021-051485
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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.

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  • Probiotic-borne AR genes could be transferred to resident potential pathogens, other microbes harbored by the host, and/or environmental microbes, thereby increasing the ecological pool of antimicrobial resistance genes.

    “one concern is the theoretical situation in which probiotic-borne AR genes could be transferred to resident potential pathogens, other microbes harbored by the host, and/or environmental microbes, thereby increasing the ecological pool of antimicrobial resistance genes.15–17”

    From Emerging issues in probiotic safety: 2023 perspectives (2023) · cites this paper as [17]

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Authors
Poindexter, B., COMMITTEE ON FETUS AND NEWBORN, Cummings, J., Hand, I., Adams-Chapman, I., Aucott, S. W., Puopolo, K. M., Goldsmith, J. P., Kaufman, D., Martin, C., & Mowitz, M.
Affiliations
Emory University (US)
ORCID
Venue
Pediatrics
Publisher
American Academy of Pediatrics (AAP)
Published
2021-06-01
Volume
147
Issue
6
ISSN
  • 0031-4005 (ISSN-L)
  • 1098-4275
DOI
10.1542/peds.2021-051485
OpenAlex
W3164637288
Semantic Scholar
4583eee007301dda92fcfd4126b59802cf396ff2
Cited by
171
References
38
Citations by year
2026: 28 · 2025: 34 · 2024: 39 · 2023: 31 · 2022: 31 · 2021: 8
FWCI
17.37
Type
journal article
Language
en
Open access
closed
Locations
  • PEDIATRICS (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Neonatal and Maternal Infections
Keywords
probiotics, preterm infants, necrotizing enterocolitis, late-onset sepsis, extremely low gestational age neonates, neonatal intensive care, FDA regulation of dietary supplements, all-cause mortality
MeSH terms
Humans, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases, Probiotics

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