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Updated: Feb 16, 2026

Electrophysiological Measurements and Analysis of Nociception in Human Infants
Published on: December 20, 2011
Lactobacillus reuteri to Treat Infant Colic: A Meta-analysis
Valerie Sung1, Frank D'Amico2,3, Michael D Cabana4
1Murdoch Children's Research Institute, The Royal Children's Hospital, and the University of Melbourne, Melbourne, Victoria, Australia; valerie.sung@rch.org.au.
Context:
Lactobacillus reuteri DSM17938 has shown promise in managing colic, but conflicting study results have prevented a consensus on whether it is truly effective.
Objective:
Through an individual participant data meta-analysis, we sought to definitively determine if L reuteri DSM17938 effectively reduces crying and/or fussing time in infants with colic and whether effects vary by feeding type.
Data Sources:
We searched online databases (PubMed, Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature, the Database of Abstracts of Reviews of Effects, and Cochrane), e-abstracts, and clinical trial registries.
Study Selection:
These were double-blind randomized controlled trials (published by June 2017) of L reuteri DSM17398 versus a placebo, delivered orally to infants with colic, with outcomes of infant crying and/or fussing duration and treatment success at 21 days.
Data Extraction:
We collected individual participant raw data from included studies modeled simultaneously in multilevel generalized linear mixed-effects regression models.
Results:
Four double-blind trials involving 345 infants with colic (174 probiotic and 171 placebo) were included. The probiotic group averaged less crying and/or fussing time than the placebo group at all time points (day 21 adjusted mean difference in change from baseline [minutes] -25.4 [95% confidence interval (CI): -47.3 to -3.5]). The probiotic group was almost twice as likely as the placebo group to experience treatment success at all time points (day 21 adjusted incidence ratio 1.7 [95% CI: 1.4 to 2.2]). Intervention effects were dramatic in breastfed infants (number needed to treat for day 21 success 2.6 [95% CI: 2.0 to 3.6]) but were insignificant in formula-fed infants.
Limitations:
There were insufficient data to make conclusions for formula-fed infants with colic.
Conclusions:
L reuteri DSM17938 is effective and can be recommended for breastfed infants with colic. Its role in formula-fed infants with colic needs further research.
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