Lubiprostone Demonstrates High Efficacy in Treating Functional Constipation in Adolescents and Children
This randomized controlled trial assessed the efficacy and safety of lubiprostone for treating functional constipation (FC) in pediatric patients, addressing the limited data available for this age group.
A total of 280 patients aged 8-18 years were randomly assigned to receive either weight-based lubiprostone (n = 140) or conventional laxatives such as lactulose, bisacodyl, or sodium picosulfate (n = 140) over 12 weeks, followed by a 4-week post-treatment follow-up.
Results showed that 91.4% of patients in the lubiprostone group achieved significant improvement in constipation compared to 34.3% in the conventional therapy group (p < 0.001), with effects sustained after discontinuation. A quarter of lubiprostone-treated patients experienced their first spontaneous bowel motion within 48 hours of initiation.
Additionally, 75.7% of the lubiprostone group maintained Bristol stool forms of 3 or 4 during the final 4 weeks of treatment and throughout the follow-up period, compared to 35.7% in the conventional group (p < 0.001). No severe adverse reactions or treatment discontinuations occurred; mild, self-limiting colicky abdominal pain and headache were the most common side effects.
Lubiprostone is shown to be an effective and well-tolerated treatment option for pediatric FC, potentially redefining the management of constipation in adolescents and children.