Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938.

Randomized, double-blind, placebo-controlled trial in exclusively breastfed infants with infantile colic in Toronto, Ontario, Canada. In the active intervention arm, 28 infants were randomized and 24 completed or were analyzed; the analyzed active-arm group had a mean gestational age of 39.9 weeks and mean age at entry of 42.1 days.

Lactobacillus reuteri DSM 17938 was given as 1 x 10^8 CFU in 5 drops of freeze-dried oral solution suspended in sunflower oil, medium-chain triglyceride oil, and silicon dioxide. Infants in the active arm received the probiotic once daily for 21 days and were compared with placebo.

Lactobacillus reuteri DSM 17938 reduced crying and fussing more than placebo and was well tolerated. By day 21, median daily crying and fussing time was 60 minutes in the probiotic group, and the total crying/fuss time over 21 days was 1719 ± 750 minutes versus 2195 ± 764 minutes in placebo. The day 21 responder rate was 17 of 24 with L. reuteri versus 6 of 28 with placebo (P = .035), and the relative risk for a at least 50% reduction was 3.3 (95% CI, 1.55-7.03). No adverse events were reported in either group.

The trial was small, with only 24 analyzed infants in the active arm, which limits precision. Follow-up was short at 21 days, and the population was restricted to exclusively breastfed infants, which limits generalizability. Some baseline dietary and outcome-related details were limited, and the intervention was evaluated in a specific clinical setting in Canada.