Randomized, Double-Blind Study of a Probiotic Sachet to Treat Infantile Colic in Babies Aged 3 to 12 Weeks

What this Trial Is About

Researchers are evaluating the effectiveness of a single strain probiotic given as a sachet to treat infant colic in babies aged 3 to 12 weeks. The study aims to understand if this probiotic can reduce symptoms like crying and fussing in infants with colic. This is a randomized, double-blinded, placebo-controlled trial sponsored by The Archer-Daniels-Midland Company. Participants will be randomly assigned to one of two groups one receiving the probiotic supplement containing 1.0E9 Colony Forming Units daily for 4 weeks, and the other receiving a placebo. The study is designed to compare the probiotic against placebo over a treatment period of 28 days. During the study, parents will record their infants crying and fussing times using an electronic diary app, and infants will be monitored for changes in symptoms, sleep time, and use of rescue medications. Visits will occur at the start and end of the 4-week treatment period, with the main measurement focusing on changes in crying and fussing time between Day 0 and Day 28.

Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief