{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["73(5)"],"submitter":["Hussain SZ"],"pubmed_abstract":["<h4>Objectives</h4>Pediatric functional constipation (PFC) affects up to 30% of children. Current treatments often do not sustain symptomatic relief. Lubiprostone is a locally acting chloride channel activator that promotes fluid secretion into the small bowel without affecting serum electrolyte concentrations. We assessed the safety/tolerability of oral lubiprostone as treatment for PFC in a 24-week study.<h4>Methods</h4>This phase 3 open-label safety trial conducted from April-November 2016 at 13 US sites included patients (ages 6-17 years) diagnosed with PFC (Rome III criteria). Patients <50 and ≥50 kg received lubiprostone 12 or 24 mcg twice daily, respectively, for 24 weeks. Safety endpoints included incidence of treatment-emergent adverse events (TEAEs) and changes from baseline in c"],"journal":["Journal of pediatric gastroenterology and nutrition"],"pagination":["572-578"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8528133"],"repository":["biostudies-literature"],"pubmed_title":["Safety of Lubiprostone in Pediatric Patients With Functional Constipation: A Nonrandomized, Open-Label Trial."],"pmcid":["PMC8528133"],"pubmed_authors":["Labrum B","Stripling S","Mareya S","Hussain SZ","Clifford R"],"additional_accession":[]},"is_claimable":false,"name":"Safety of Lubiprostone in Pediatric Patients With Functional Constipation: A Nonrandomized, Open-Label Trial.","description":"<h4>Objectives</h4>Pediatric functional constipation (PFC) affects up to 30% of children. Current treatments often do not sustain symptomatic relief. Lubiprostone is a locally acting chloride channel activator that promotes fluid secretion into the small bowel without affecting serum electrolyte concentrations. We assessed the safety/tolerability of oral lubiprostone as treatment for PFC in a 24-week study.<h4>Methods</h4>This phase 3 open-label safety trial conducted from April-November 2016 at 13 US sites included patients (ages 6-17 years) diagnosed with PFC (Rome III criteria). Patients <50 and ≥50 kg received lubiprostone 12 or 24 mcg twice daily, respectively, for 24 weeks. Safety endpoints included incidence of treatment-emergent adverse events (TEAEs) and changes from baseline in c","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Nov","modification":"2026-05-08T16:16:04.075Z","creation":"2025-02-19T00:02:59.093Z"},"accession":"S-EPMC8528133","cross_references":{"pubmed":["34387619"],"doi":["10.1097/MPG.0000000000003280"]}}