to Treat Infant Colic: A Meta-analysis.

Context: 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 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 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: DSM17938 is effective and can be recommended for breastfed infants with colic. Its role in formula-fed infants with colic needs further research.