Evaluating Anorectal Manometry and Lubiprostone Treatment for Children Ages 4 to 16 with Chronic Refractory Constipation with or without Fecal Incontinence

What this Trial Is About

Researchers are investigating anorectal manometry, including high-resolution anorectal manometry HRAM, in children aged 4 to 16 with chronic refractory constipation, with or without fecal incontinence. The study aims to understand whether symptoms are related to sphincter problems, impaired sensation, or pelvic floor muscle issues. It also evaluates different treatments based on these anorectal findings, focusing especially on the safety and effectiveness of lubiprostone and the impact of eliminating cow milk products in affected children. All participants will receive the drug lubiprostone, which is a laxative, administered orally at doses of 8 and 24 micrograms once daily for four weeks. Additional treatments include biofeedback sessions for children with dyssynergic defecation or reduced rectal sensation and botulinum toxin injections for those with elevated anal canal pressure. The study has a single treatment arm where all children receive these interventions as applicable based on their anorectal manometry results. During the study, children will be assessed through manometric tests to evaluate anorectal function over one year and the effectiveness of lubiprostone after one month. Secondary assessments include the impact of biofeedback sessions, cow milk protein-free diet, and botulinum toxin injections over several months. Participants will keep diaries and complete questionnaires to track symptoms. Safety, tolerability, and treatment outcomes will be monitored throughout the study, which runs until October 2025.

Anorectal Manometery in Pediatric Chronic Refractory Constipation