Lactobacillus acidophilus for infant colic and microbiota modulation: a randomized clinical trial
We aimed to evaluate the efficacy of Lactobacillus acidophilus NCFMversus placebo in improving the proportion of responders in infants with colic. From a total of 3,369 screened infants, a double-blind, placebo-controlled randomized trial was conducted with 60 infants with colic, randomly assigned to receive five drops of L. acidophilus NCFM (1x10 9 CFU) or placebo for 28 days. Data on responders, daily fussing and crying time, adverse effects, and maternal and child characteristics were collected. Changes in gut microbiota and fecal calprotectin were also evaluated. The study was registered at ensaiosclinicos.gov.br (RBR-5pp4nks).