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.