Probiotics in pediatrics: Evidence, product quality, and safety

Evidence supporting probiotic use in children was strongest for antibiotic-associated diarrhea (AAD), whereas data for infantile colic were lacking and use for necrotizing enterocolitis remained limited by safety concerns, according to Mark R. Corkins, MD, CNSC, FASPEN, AGAF, FAAP, who presented "Tiny Bugs, Big Impact: Prebiotics and Probiotics in Pediatric Care" at the American Academy of Pediatrics 2026 National Conference & Exhibition.

Within AAD, the most robust literature supported probiotics for prevention of Clostridioides difficile infection, Corkins said, and evidence for preventing AAD more broadly was reasonable.¹ In contrast, no data supported probiotic use for infantile colic. For necrotizing enterocolitis, some literature supported probiotic use, but other studies raised safety issues, and the approach was not yet ready for routine practice, according to Corkins, a pediatric gastroenterologist at Le Bonheur Children's Hospital at the University of Tennessee Health Science Center in Memphis, Tennessee.²

Selecting a product was complicated by the lack of oversight, Corkins said. Probiotics were classified as food supplements rather than medications and therefore were not regulated as drugs. Independent testing found that some bottles contained no probiotic organisms at all, and others contained bacteria that did not match the strain listed on the label. Corkins recommended that families choose more established brands that had been used in clinical studies and had been on the market longer, noting that a recognizable brand was the preferred choice.

Because probiotics were living organisms, they carried risk in vulnerable populations. Reports had described bacteremia following probiotic use in fragile, immunocompromised patients, according to Corkins, who noted that bacteremia was a more accurate description of these events than sepsis.

"With the already weakened immune system, maybe something that's not harmful in somebody who has a normal immune system might be," Corkins said. Given these safety concerns, he recommended against probiotic use in immunocompromised children.

When families asked about the many probiotic supplements and probiotic-labeled foods available, counseling centered on separating risk from benefit. In children with a normal immune system and a normal gastrointestinal tract, harm from probiotics was unlikely, Corkins said. Benefit was a separate question, and the evidence was mixed, with many studies showing no harm but also no benefit.

"You really can't say, ‘everybody should be on a probiotic,’ because the data is not there to support doing that," Corkins said.

References

1. Guo Q, Goldenberg JZ, Humphrey C, et al. Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane Database Syst Rev. 2019;4(4):CD004827. https://doi.org/10.1002/14651858.CD004827.pub5

2. Poindexter B; American Academy of Pediatrics Committee on Fetus and Newborn. Use of probiotics in preterm infants. Pediatrics. 2021;147(6):e2021051485. https://publications.aap.org/pediatrics/article/147/6/e2021051485/180282/Use-of-Probiotics-in-Preterm-Infants