Probiotics in Preterm Infants and Necrotizing Enterocolitis: Hospital Use and FDA Warning
Hospital use of probiotics in premature babies, what reviews found for necrotizing enterocolitis, and the FDA warning about serious infection; never a decision for home.
Content last updated . This page has not been medically reviewed.
Urgent first: this is a hospital decision, never a home one
Do not give a probiotic to a premature baby on your own. The US FDA (October 2023) said preterm infants given a probiotic product are at risk of "invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics." [1] It also said it has not approved any probiotic product as a drug or biological product for infants of any age. [1] If your baby is in a neonatal unit, ask the neonatal team what, if anything, is being given and why. If you are worried that a baby is seriously unwell, contact the baby's clinician; in a US emergency, call 911.This page is information only. It cannot tell you whether a particular baby should receive a probiotic.
What necrotizing enterocolitis is
Necrotizing enterocolitis (NEC) is a serious, sometimes fatal disease of premature infants in which parts of the intestine are damaged. Its exact cause is unknown. [2] Some neonatal units give specific probiotic products to very small babies to prevent NEC; the FDA says certain products are used in hospital settings for that purpose. [1] That practice is the subject of the evidence below and of a real disagreement between regulators and pediatric societies.What the research found
Evidence labels used here: promising but limited (some benefit in trials but low or moderate certainty), mixed, insufficient evidence, and evidence of harm (reported serious infections). Trials gave many different products, so results are not about "probiotics" as one thing. [3]| Question | What the source found | Strength of evidence |
|---|---|---|
| Do probiotics lower NEC in very preterm or very low birth weight babies? | A 2023 Cochrane review of 60 trials (11,156 infants) found probiotics may reduce NEC (RR 0.54; low certainty) and probably reduce mortality slightly (RR 0.77; moderate certainty). [3] | Promising but limited |
| What about extremely preterm babies? | In that group the same review found probiotics may have little or no effect on NEC (RR 0.92; low certainty). [3] | Insufficient evidence |
| Does the type of product matter? | A 2023 network meta-analysis of 106 trials (25,840 preterm infants) found only multiple-strain probiotics were associated with lower all-cause mortality than placebo. [4] | Promising but limited |
| Did trials use the same products? | The Cochrane review notes the formulation varied across trials. [3] | Limits what can be concluded |
| Can the products cause infection? | A 2022 review found 32 preterm infants with sepsis caused by the given probiotic strain, mostly Bifidobacterium, and called the event relatively uncommon. [5] | Evidence of harm (rare, in case reports and series) |
| Can a product be contaminated? | A case report linked gastrointestinal fungal disease in a 29-week infant to contaminated probiotic powder. [6] | Evidence of harm (case report) |
The AGA technical review (US, 2020) said the data strongly suggested probiotics may protect premature infants from mortality and do not increase rates of sepsis. It also said risks and benefits should be considered carefully "given the possibility of manufacturing contaminants." [7] The AGA guideline wording itself could not be read for this page.
NCCIH (US) says the long-term effects of giving probiotics at such a young age are uncertain, and that outside studies there have been cases of harm in newborns. [2]
The FDA warning and the disagreement
In October 2023 the FDA said certain probiotic products used in hospitals to prevent NEC had contributed to invasive disease, including one infant death in 2023, and had been associated with more than two dozen other reported adverse events in the US since 2018. [1] It acknowledged conflicting data on safety and effectiveness for NEC prevention and said different studies used different probiotics. [1]In 2024 members of the European pediatric gastroenterology society ESPGHAN and the European Foundation for the Care of Newborn Infants responded, advocating a "more nuanced and supportive approach to the use of certain probiotics" in this population. [8] So US and European bodies do not speak with one voice, and the question is under active debate. Either way the decision sits with the neonatal team, which knows the baby's weight, age, feeding and infection risk.
What this means for parents and carers
- Do not buy a probiotic for a premature baby, without the neonatal team's instruction. The FDA said such products are not approved for infants of any age. [1]
- Ask the team which product, if any, is used, whether it was tested for contamination, and what signs of infection to watch for.
- Report any adverse event to the care team; the FDA encourages reporting to its MedWatch program. [1]
- For older, healthy full-term babies see probiotics for infants and babies and probiotics for infant colic.
Related safety pages: probiotic safety, bloodstream infection and contamination and recalls. Never stop or change a medicine for a baby without asking the prescriber.
Frequently asked questions
Can I give my premature baby a probiotic at home?
No. The FDA warned that preterm infants given probiotic products risk serious, potentially fatal infection, and only the neonatal team can decide about hospital use. [1]
Do probiotics prevent NEC?
A 2023 Cochrane review found they may reduce NEC in very preterm or very low birth weight babies (low certainty), but probably little or no effect in extremely preterm babies. [3]
Why do the FDA and European pediatric societies disagree?
The FDA focused on infections and unapproved products; ESPGHAN and a neonatal foundation argued for a more nuanced approach to certain probiotics. [1][8]
Is probiotic infection common in premature babies?
A 2022 review called it relatively uncommon, based on 32 cases in reports and series, most of whom recovered with antimicrobial treatment. [5]
Are probiotic products for premature babies approved in the US?
The FDA says it has not approved any probiotic product as a drug or biological product for infants of any age. [1]
References
- US Food and Drug Administration. FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants. News release, 26 October 2023. Read 2026-10-23.
- NCCIH (US National Center for Complementary and Integrative Health). Probiotics: Usefulness and Safety. Page shows "Last Updated: August 2019" with later FDA 2023 content. Read 2026-10-23.
- Sharif S et al. Cochrane Database Syst Rev 2023. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. PMID 37493095. Read 2026-10-23.
- Wang Y et al. JAMA Pediatr 2023. Probiotics, Prebiotics, Lactoferrin, and Combination Products for Prevention of Mortality and Morbidity in Preterm Infants: A Systematic Review and Network Meta-Analysis. PMID 37782505. Read 2026-10-23.
- Kulkarni T et al. Eur J Pediatr 2022. Probiotic sepsis in preterm neonates-a systematic review. PMID 35348825. Read 2026-10-23.
- Bizzarro MJ et al. Pediatr Infect Dis J 2021. Gastrointestinal Zygomycosis in a Preterm Neonate Associated With Contaminated Probiotics. PMID 33464011. Read 2026-10-23.
- Preidis GA et al. Gastroenterology 2020. AGA Technical Review on the Role of Probiotics in the Management of Gastrointestinal Disorders. PMID 32531292. Full text read via PMC8018518. The companion AGA guideline text could not be read. Read 2026-10-23.
- van den Akker CHP et al. J Pediatr Gastroenterol Nutr 2024. Reevaluating the FDA's warning against the use of probiotics in preterm neonates: A societal statement by ESPGHAN and EFCNI. PMID 38572770. Abstract only read. Read 2026-10-23.