Background. There is controversy regarding whether hypersensitivity to food proteins contributes to colic among breastfed infants.

Methods. A randomized, controlled trial of a low-allergen maternal diet was conducted among exclusively breastfed infants presenting with colic. In the active arm, mothers excluded cow's milk, eggs, peanuts, tree nuts, wheat, soy, and fish from their diet; mothers in the control group continued to consume these foods. Outcomes were assessed after 7 days, as the change in cry/fuss duration over 48 hours, with validated charts. The primary end point was a reduction in cry/fuss duration of ≥25% from baseline. Mothers also assessed the responses to diet with categorical and visual analog scales.

Results. Of 107 infants, 90 completed the trial (mean age: 5.7 weeks; range: 2.9–8.6 weeks; 54 male infants). Infants in both groups presented with significant distress (geometric mean: low-allergen group: 690 minutes per 48 hours; control group: 631 minutes per 48 hours). In follow-up assessments on days 8 and 9, there were significantly more responders in the low-allergen group (74% vs 37%), ie, an absolute risk reduction of 37% (95% confidence interval: 18–56%). Cry/fuss duration per 48 hours was reduced by a substantially greater amount in the low-allergen group; the adjusted geometric mean ratio was 0.79 (95% confidence interval: 0.63–0.97), ie, an average reduction of 21% (95% confidence interval: 3–37%). Mothers' subjective assessments of the responses to diet indicated little difference between the groups.

Conclusion. Exclusion of allergenic foods from the maternal diet was associated with a reduction in distressed behavior among breastfed infants with colic presenting in the first 6 weeks of life.

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