Use of Domperidone to Treat Children and Young Adults Aged 12 to 21 with Difficult-to-Treat Gastroparesis and GERD

What this Trial Is About

This research aims to allow the use of domperidone in children and young adults aged 12 to 21 who have symptoms related to gastrointestinal motility disorders and Gastroesophageal Reflux Disease GERD that have not improved with standard treatments. The study focuses on people with symptoms such as persistent esophagitis, heartburn, nausea, vomiting, severe dyspepsia, or severe chronic constipation, all linked to these conditions. Participants will take domperidone four times daily, with the dose adjusted based on their weight. Before starting treatment, participants will undergo a medical history review, physical examination, ECG, blood tests, and pregnancy test if female to ensure safety. During the first year, physical exams, blood draws, and ECGs will occur every two months. After one year, if treatment is beneficial, these checks will continue every six months until the medication is stopped. Throughout the study, participants will have regular health assessments including heart and breathing rates, blood pressure, height, weight, and blood tests to monitor domperidone levels. ECGs will be performed to monitor heart function, especially if the dose increases. The main outcome measured is the change in disease severity over up to one year. The total study period extends until December 2035, allowing long-term monitoring.

Compassionate Use of Domperidone for Refractory Gastroparesis