Study Comparing New Polyethylene Glycol Formula to Standard Treatment for Children with Functional Constipation

What this Trial Is About

Researchers are evaluating the effectiveness and taste of a newly developed polyethylene glycol PEG-based formula compared to the standard PEG formula in treating children with functional constipation. This study includes children aged 6 months to 18 years diagnosed with functional constipation based on ROME IV criteria. The study also aims to assess side effects and changes in rectal diameter over time between the two treatment groups. Participants will be randomly assigned to one of two groups Group A will receive the developed PEG-Chula formula, which includes sweeteners and flavors, at a dose of 0.5 to 1 gkgday for 56 days. Group B will receive the standard PEG formula Forlax at the same dose and duration. Both treatments come in similar sealed sachets to ensure blinding. Throughout the study, all children will receive counseling on toilet training, water intake, and fiber intake. Children will visit the researchers on days 7, 14, 28, and 56 to monitor symptoms, stool frequency and consistency, bowel size via ultrasound, side effects, and medication adherence. Parents will keep a logbook of symptoms, diet, and medication doses. The primary outcomes measured include stool frequency and consistency, while secondary outcomes include fecal incontinence, rectal measurements, palatability assessed by a facial Hedonic scale, adverse events, and gut microbiota changes. Monitoring will continue up to 2 years for some measures. Children with poor adherence may be excluded from the study.

The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation