Study of Probiotic Limosilactobacillus Reuteri Drops to Reduce Crying and Fussing in Infants With Colic

What this Trial Is About

Researchers are evaluating the effect of the probiotic Limosilactobacillus reuteri L. reuteri on reducing crying and fussing time in infants with colic. This is a double-blind, randomized, placebo-controlled study designed to better understand how this dietary supplement may influence infantile colic symptoms. The primary focus is to measure changes in crying and fussing time, which are common concerns for infants with colic and their families. In this study, infants will be randomly assigned to receive either L. reuteri drops or a placebo once daily for 21 consecutive days. Both groups receive identical-looking drops to maintain the studys blindness. The trial includes multiple visits during the treatment period and monitors various outcomes such as crying and fussing time, family quality of life, sleeping time, and maternal depression. Participants will be involved in regular visits on Day 0, Day 8, and Day 22, during which physical exams and assessments will be performed. Parents or caregivers will complete diaries and questionnaires to track the infants crying and fussing patterns, sleep, and overall family impact. The main outcome measured is the change in crying and fussing time from baseline to Day 7, with additional follow-up until Day 21. Safety and health of the infant will be monitored throughout the study period.

Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic