Are probiotics safe for babies?

It depends on the baby. For premature babies there are serious warnings,^[1] and in trials of other babies no serious side effects were reported.^[2]

Premature babies. The US FDA warns that they can get invasive, possibly fatal infections from the microbes. It reported one death in 2023 and more than two dozen other adverse events since 2018. No probiotic has FDA approval as a drug for babies of any age.^[1] The American Academy of Pediatrics does not support routine use, particularly under 1000 g at birth.^[3] A Cochrane review of 60 trials found that probiotics may lower the risk of necrotizing enterocolitis, a serious bowel disease, in very premature babies (risk ratio 0.54, low certainty). In extremely premature babies, they may have little or no effect.^[4] The World Health Organization says that probiotics may be considered for babies born before 32 weeks who get human milk.^[5]

Other babies. In a Cochrane review of 24 studies with 7077 mothers and babies, there were no serious side effects, and the evidence was too limited to say that probiotics prevent allergies.^[2] In babies with colic, Limosilactobacillus reuteri DSM 17938 cut crying and fussing by about 25 minutes a day at day 21, with a clear effect only in breastfed babies. This result applies to that strain.^[6]