Study on the Effects of B. lactis B94 Probiotic on Reducing Symptoms of Infantile Colic in Babies Up to 8 Weeks Old

What this Trial Is About

Researchers are evaluating the effects of the probiotic B. lactis B94 on infants with infantile colic. The study aims to see if this probiotic can reduce the duration of crying in infants compared to a placebo. This is a randomized, double-blind, placebo-controlled trial designed to provide clear evidence on the potential benefits of B. lactis B94 for infantile colic symptoms. Participants will be randomly assigned to one of two groups one receiving the probiotic B. lactis B94 and the other receiving a placebo. Both groups will take one sachet daily, dissolved in 10 ml of lukewarm water, for 4 weeks. The study includes a 1-week baseline period before treatment and a 1-week follow-up after the intervention. The trial involves three in-person visits and four phone calls. During the 6-week participation, caregivers will complete questionnaires, keep diaries, and attend scheduled visits and calls to monitor the infants crying, sleep, bowel habits, and quality of life. Researchers will measure changes in daily crying duration, crying patterns, sleep time, gut bacteria composition, and probiotic recovery. Safety and adherence will be tracked throughout the study, ensuring detailed observation of all participants.

Effect of Probiotics on Infantile Colic Symptoms