Constipation affects up to 65 per cent of autistic children, roughly three times the rate in the general population, and drives disproportionate emergency visits and hospital admissions, yet there is little evidence on which treatments actually work for this group, who often cannot tolerate or do not respond to standard approaches. A new $12.9 million award from the Patient-Centered Outcomes Research Institute will fund a trial designed to change that.
Pediatric gastroenterologists Bruno Chumpitazi of Duke and Michael Kappelman of the University of North Carolina at Chapel Hill will serve as co-principal investigators. The multi-site randomised trial will compare linaclotide head to head with PEG-3350, the current standard treatment, aiming to enrol 320 patients across 30 sites nationwide, with the Duke Clinical Research Institute acting as the site and data coordinating centre for the study.
The investigators expect the findings to reach beyond autism, informing constipation care for children generally. The design also reflects a deliberate emphasis on involving families, with UNC's patient and community engagement programme serving as the trial's engagement hub. For parents who have cycled through treatments their children cannot tolerate, the study promises something rare in this corner of paediatrics: evidence built around their circumstances.