Efficacy of Lactobacillus reuteri DSM 17938 in preterm newborns and infants with colic: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE

Early-life gut microbiota is crucial for gastrointestinal and immune development. Dysbiosis has been implicated in infantile colic and in complications of prematurity, including feeding intolerance and necrotizing enterocolitis (NEC). Lactobacillus reuteri DSM-17938 has been proposed as a strategy to modulate gut homeostasis during early infancy.

METHODS

We conducted a systematic review and meta-analysis of randomized, placebo-controlled trials evaluating single-strain L. reuteri DSM-17938 in newborns and infants (0-12 mo). PubMed, Scopus, Web of Science, and the Cochrane Library were searched from 2008 to October 2025. Two separate meta-analyses were conducted for colicky infants and preterm newborns. Primary outcomes were treatment response in colic (≥50% reduction in crying time) and feeding intolerance in preterms. Secondary outcomes for preterms included daily crying time, NEC, sepsis, time to full enteral feeding, and length of hospital stay.

RESULTS

About 11 randomized, placebo-controlled trials involving infants with colic (n = 555), and eight involving preterms (n = 1704) were included. In colicky infants, L. reuteri DSM-17938 significantly increased treatment response compared with placebo (OR 6.98;95% CI 2.26-21.59) and significantly reduced daily crying time (SD -2.61;95% CI -3.98 to-1.24). In preterms, probiotic supplementation reduced the incidence of feeding intolerance (OR 0.57; 95% CI 0.42-0.79) and NEC (OR 0.49; 95% CI 0.31-0.77), with earlier achievement of full enteral feeding and shorter hospitalization. No significant effect on sepsis was observed, and no safety concerns emerged.

CONCLUSIONS

L. reuteri DSM-17938 may be associated with benefits in infantile colic and selected gastrointestinal outcomes in preterm newborns. Further well-designed trials are needed to confirm these findings.