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Linaclotide: A New Option For Chronic Pediatric Constipation

Linaclotide: A New Option For Chronic Pediatric Constipation 1024 668 Pam Georgiana

Phase 3 Trial at Nationwide Children’s Supports Safety and Efficacy in Children Aged 6–17.

Constipation, a common issue for children, can be a source of prolonged struggle and distress for young patients and their families. Despite many treatments being available, some children continue to battle with this condition for years. There is a lack of high-quality research on medications suitable for treating children with chronic constipation. Carlo Di Lorenzo, MD led a recent randomized, double-blind, placebo-controlled, multicenter research study published in The Lancet Gastroenterology & Hepatology.

“We know that linaclotide is a well-tolerated treatment for chronic constipation in adults with few side effects. We wondered if it would do the same for children,” explains Dr. Di Lorenzo. He is the chief of the Division of Pediatric Gastroenterology, Hepatology and Nutrition at Nationwide Children’s and professor of Clinical Pediatrics at The Ohio State University College of Medicine.

Conducted at 64 sites in seven countries, the trial enrolled 330 pediatric patients aged 6 to 17 years who met the criteria for functional constipation. Researchers randomized participants to receive either linaclotide or a placebo daily for 12 weeks. The researchers were looking for changes in weekly spontaneous bowel movements and improvements in stool consistency.

By the end of the 12 weeks, patients in the linaclotide group showed a significant increase in bowel movement frequency compared with the placebo group. In addition, stool consistency also improved in the linaclotide group. The most reported adverse side effect of the drug was diarrhea, which was not severe. The study reported no serious side effects or deaths.

“Linaclotide is not systemically absorbed into the bloodstream,” Dr. Di Lorenzo explains, “which likely contributes to its favorable side effect profile and minimal adverse effects.”

Until now, pediatricians have relied heavily on treatments that, despite widespread use, lack formal FDA approval for children. This large, placebo-controlled trial is the first to provide conclusive evidence of linaclotide’s efficacy in children. The medication is readily available in capsule form, which can be broken apart for children to easily swallow.

“This study led to the FDA approval of the use of linaclotide in children aged 6 and older,” says Dr. Di Lorenzo. “Pediatricians can now consider it a safe and effective treatment option for children and adolescents, hopefully improving their quality of life significantly.”

Reference

Di Lorenzo C, Khlevner J, Rodriguez-Araujo G, et al. Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Gastroenterol Hepatol. 2024;9(3):238-250. doi:10.1016/S2468-1253(23)00398-9

About the author

Pam Georgiana is a brand marketing professional and writer located in Bexley, Ohio. She believes that words bind us together as humans and that the best stories remind us of our humanity. She specialized in telling engaging stories for healthcare, B2B services, and nonprofits using classic storytelling techniques. Pam has earned an MBA in Marketing from Capital University in Columbus, Ohio.

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