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In a nonblinded, randomized clinical trial, the probiotic Lactobacillus reuteri significantly reduced crying in breast-fed infants with colic compared with simethicone (JW Pediatr Adolesc Med Jan 24 2007). Now, in an industry-funded, double-blind, randomized trial, investigators compared crying time in 46 healthy breast-fed infants (age range, 2–16 weeks) with colic who received five drops of a L. reuteri or placebo once daily before the morning feeding for 21 days. Infants were recruited consecutively from a single hospital in Italy.
At enrollment, all infants cried for more than 180 minutes per day (median, about 300 minutes). On day 21, the percentage of infants who cried for more than 180 minutes per day (the primary outcome) was signifi…