Duke University announced on Apr. 28 that it has received $12.9 million from the Patient-Centered Outcomes Research Institute to fund a new clinical trial focused on improving care for autistic children who experience chronic digestive discomfort.
The research will be co-led by Duke and University of North Carolina at Chapel Hill, highlighting their collaboration through NC Children’s, the state’s first freestanding children’s hospital. The hospital is scheduled to begin construction in Apex, North Carolina in 2027.
Pediatric gastroenterologists Bruno Chumpitazi of Duke and Michael Kappelman of UNC will serve as co-principal investigators. The Duke Clinical Research Institute will act as the site and data coordinating center, while UNC’s Patient and Community Engagement in Research Program will manage patient engagement efforts.
Up to 65 percent of autistic children experience constipation, which is about three times higher than among other children. This can lead to irritability, social withdrawal, disruption of daily routines, and self-injury. “We see firsthand that standard treatments don’t always work well for autistic children, where sensory sensitivities, diet, and medication tolerance can complicate care,” said Chumpitazi. “This study is designed to generate clear, evidence-based guidance that clinicians and families can use.” Kappelman said: “For autistic children, constipation is associated with a higher number of emergency department visits and hospitalizations. Determining better evidence-based treatments may make a major difference.” He also described the project as “a wonderful collaboration between our two pediatric programs and a great example of what we can accomplish together through NC Children’s.”
The trial will compare linaclotide with polyethylene glycol 3350 (commonly known as MiraLAX), recruiting about 320 patients from 30 sites nationwide across various pediatric practices at both large hospitals and smaller clinics.
Geeta Swamy said: “This study reflects the kind of collaboration we are building through NC Children’s—bringing together Duke’s research infrastructure and UNC’s patient engagement expertise to improve care for children across the country.”
Located in Durham since its founding in 1925, Duke University Hospital admitted over 41,000 patients in calendar year 2022 according to their annual report.