Duke and UNC researchers are teaming up on a $12.9 million national clinical trial that zeroes in on a problem many families of autistic children quietly battle every day: chronic constipation. The study aims to enroll 320 patients at roughly 30 sites across the country and will randomly compare two medications, linaclotide and polyethylene glycol 3350 (better known as MiraLAX), to see which one works better and is easier for kids to tolerate. For families like 9-year-old Nova Horton of Raleigh and her mother, who say long-standing gastrointestinal problems have shaped daily life, the need for better answers is not theoretical at all.
New funding and who’s leading the trial
According to Duke Health, the Patient-Centered Outcomes Research Institute has signed off on $12.9 million in funding for the project. The Duke Clinical Research Institute will serve as the site and data coordinating center, while UNC’s patient and community engagement program will lead the charge on working with families. The award supports a multi-site, randomized trial co-led by Duke pediatric gastroenterologist Bruno Chumpitazi and UNC’s Michael Kappelman. PCORI’s formal award contract is still pending, but the framework of the study is already in place.
How common - and how hard - is constipation in autistic kids?
A nationwide electronic-health-record review found that about 22% of autistic children had a documented constipation diagnosis, compared with 9% of nonautistic youth, and the affected children had higher rates of emergency-department visits and hospitalizations, according to Am J Gastroenterol. Other research paints an even tougher picture: depending on study design, parent surveys and some reviews report much higher gastrointestinal symptom rates, climbing to roughly two-thirds of children in some analyses, per a recent PsychiatryOnline systematic review.
Why linaclotide is on the table
Linzess (linaclotide) already has FDA approval for treating pediatric functional constipation in patients 6 to 17 years old, according to the FDA. Researchers have also noted that the capsule can be opened and the contents mixed into food or liquid, which could be a big plus for children with sensory-related feeding issues, as reported by WRAL. Polyethylene glycol 3350, meanwhile, remains the workhorse first-line osmotic laxative in many pediatric clinics, in line with NASPGHAN/ESPGHAN guidance.
Families welcome clearer answers
“It has been challenging. It's been difficult,” Amber Horton told WRAL, describing the long trail of appointments, testing, and constant advocating for her daughter’s care. Parents in similar situations say they hope clearer, head-to-head evidence will mean fewer frantic trips to emergency departments, fewer hospital stays tied to constipation, and more concrete, practical treatment plans that front-line clinicians can lean on.
Next steps and how the study will roll out
The research team plans to recruit patients from general pediatrics, developmental pediatrics, and pediatric gastroenterology clinics, drawing from both large freestanding children’s hospitals and smaller practices. Enrollment will be coordinated through the Duke Clinical Research Institute along with UNC’s patient-engagement program, according to UNC Health. Investigators say patients and parent partners will not just be subjects but integral members of the study team, and outreach to families at participating sites is expected to ramp up later this year.
Why this matters in North Carolina
The trial is one of the earliest flagship projects linked to NC Children’s, the freestanding children’s hospital that Duke Health and UNC Health are developing in Apex. NC Children’s reports that construction planning is underway and that groundbreaking is expected to begin in 2027. Local clinicians say the constipation study’s results could reshape care protocols across North Carolina and beyond, with the potential to improve quality of life for many children while easing the load on families and already stressed emergency services.
