Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Including L. Reuteri) in Children With Functional Constipation: a Double Blind Randomized Control Trial

What this Trial Is About

Researchers are evaluating whether the probiotic supplement BioKid LR®, which contains nine different species of probiotic bacteria including L. Reuteri, can help children aged 6 months to 17 years with functional constipation maintain normal bowel movements after stopping laxative treatment with PEG 3350. The study aims to find out if BioKid LR can reduce the chance of constipation returning and if it can help children avoid restarting laxatives. This trial is a double-blind, randomized controlled study involving 80 children. Participants will first take PEG 3350 along with either the BioKid LR probiotic or a placebo daily for 12 weeks. Then, they will gradually stop the PEG while continuing with either BioKid LR or placebo for another 12 weeks. After this, children will continue only with BioKid LR or placebo for an additional 28 weeks, making the total study duration 52 weeks. The two study groups include one receiving the probiotic supplement and the other receiving an inactive maltodextrin powder as placebo. During the study, participants will keep a stool diary to monitor bowel habits and any side effects. They will attend five study visits for physical exams and monitoring at weeks 0, 12, 24, 38, and 52. Researchers will mainly measure how long it takes for constipation to return after stopping PEG treatment and if retreatment is needed. Secondary outcomes include the number of children needing long-term treatment, regular bowel movements without accidents in children over 4 years old, stool consistency, and frequency. Safety and overall progress will be monitored throughout the year-long study.

Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation