Effectiveness of the extensively hydrolyzed formulas in the management of infantile colic: A systematic review and meta-analysis.

Abstract

<h4>Background</h4>Infantile colic (IC) is a common, self-limiting condition marked by excessive, unexplained crying. Evidence on the use of extensively hydrolyzed formulas (eHFs) as a dietary intervention remains fragmented.<h4>Aim</h4>To systematically review and meta-analyze the effectiveness of eHFs in managing symptoms of IC.<h4>Methods</h4>A comprehensive literature search of MEDLINE, Cochrane and Web of Science databases (1980-2025) identified randomized controlled trials and crossover studies assessing the efficacy of eHF in infants diagnosed with IC based on Wessel's or ROME III criteria. Studies were included if they involved infants ≤ 6 months old on partial or exclusive formula diets, and were excluded if the diagnosis was unclear. Data were synthesized qualitatively and through meta-analysis using odds ratios (OR) and 95% confidence intervals (CI).<h4>Results</h4>Six studies met the inclusion criteria, with a total of 340 infants across intervention and comparator arms. In all studies, eHF significantly reduced crying duration and colic symptoms compared to regular formula or dicyclomine. The meta-analysis showed a pooled OR of 4.8 (95%CI: 2.53-9.11, <i>P</i> < 0.05). Secondary outcomes such as stool consistency and parental quality of life were variably reported but tended to favor eHF.<h4>Conclusion</h4>eHF appear significantly more effective than standard formulas and pharmacologic comparators in reducing colic-related symptoms. These findings support eHF as a viable dietary intervention for IC, though larger, well-controlled trials are warranted to confirm long-term outcomes.