Trial Suggests Lubiprostone is Safe in Children With Functional Constipation

Investigators sought to analyze the safety and tolerability of oral lubiprostone in children with functional constipation.

Lubiprostone appears to be safe for use in children with functional constipation, according to study results published in the Journal of Pediatric Gastroenterology and Nutrition.

Despite the common use of laxatives for managing childhood chronic constipation, data on their safety, efficacy, and tolerability are limited, and no trials have examined the long-term benefits of these medications in pediatric functional constipation. Lubiprostone is approved for use in adult populations for chronic idiopathic constipation. In this current study, investigators sought to analyze the safety and tolerability of oral lubiprostone in children with functional constipation.

Investigators conducted a phase 3, open-label, nonrandomized, safety trial at 13 centers in the United States between April 12, 2016 and November 4, 2016. Patients meeting Rome III criteria for childhood functional constipation received lubiprostone twice daily for 24 weeks at a dose based on weight: 12 mcg for patients weighing less than 50 kg and 24 mcg for those weighing 50kg or more.

Safety outcomes included incidence of treatment-emergent adverse events (TEAEs) and changes from baseline in clinical laboratory parameters and vital signs.

The mean age of the study population was 8.8 years; 56.3% of the participants were girls. Of the 87 patients who received lubiprostone, 64.3% in the 12-mcg group (n=36/56) and 54.8% (n=17/31) in the 24-mcg group completed the study.

Overall, TEAEs were mild in intensity, with diarrhea and vomiting most frequently reported; 57.1% and 48.4% of patients from the 12- and 24-mcg groups reported having more than one TEAE, respectively. Twelve patients discontinued the study due to upper abdominal pain. No safety concerns were observed in clinical tests and vital signs.

The mean investigators’ assessment of treatment effectiveness (on a scale of 0 to 4) for the lubiprostone 12- and 24-mcg groups were determined to be moderate to quite a bit effective. Scores were reported as the following for the lubiprostone 12- and 24-mcg groups: 2.8 and 2.9 at week 12, and 2.7 and 2.2 at week 24, respectively.

Study limitations included the small sample size as well as the nonblinded and nonrandomized study design that didn’t include a placebo control.

Investigators concluded, “[T]his study in pediatric patients has shown that both lubiprostone 12 mcg [twice daily] and lubiprostone 24 mcg [twice daily] administered orally were well tolerated, with no evidence of clinically significant safety concerns.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Hussain SZ, Labrum B, Mareya S, Stripling S, Clifford R. Safety of Lubiprostone in pediatric patients with functional constipation: a nonrandomized, open-label trial. J Pediatr Gastroenterol Nutr. 2021;73(5):572-578. doi:10.1097/MPG.0000000000003280