Researchers conducted a systematic review of 12 trials that randomized 1,825 infants three months or younger to oral probiotics vs. placebo, or to no or standard treatment. Five of the trials examined the effectiveness of probiotics in the treatment of infant colic and seven examined their role in infant colic prevention. The outcome was the duration or number of episodes of infant crying/distress or diagnosis of "infant colic."
According to study findings, six of the 12 trials suggested probiotics reduced crying and six did not. Three of the five management trials concluded probiotics effectively treat colic in breastfed babies; one suggested possible effectiveness in formula-fed babies with colic, and one suggested ineffectiveness in breastfed babies with colic. "Larger and more rigorously designed randomized clinical trials are needed to examine the efficacy of the probiotic L reuteri in the management of breastfed and particularly formula-fed infants with colic and in the prevention of colic in healthy term infants," the study concludes.