Comparing Prucalopride and Famotidine to Treat Aspiration Symptoms in Children and Young Adults with Neurologic Impairment and Digestive Motility Issues

What this Trial Is About

Researchers are studying children and young adults aged 5 to 21 years with neurologic impairment and digestive motility problems to understand the risk of aspiration-related symptoms. The study compares two medications, prucalopride and famotidine, to see how they affect aspiration symptoms in this population. The trial is a phase 4, randomized, triple-blind crossover study conducted by Boston Childrens Hospital. Participants will undergo a 10-week crossover treatment period starting with a 1-week observation, then 4 weeks of either prucalopride or famotidine, followed by a 1-week washout, and then 4 weeks of the alternate medication. Prucalopride is given at 0.04 mgkgday and famotidine at 0.4 mgkgday. Two study arms exist to compare the order of medication administration. During the study, participants will be assessed using the Pediatric Cough Quality of Life Questionnaire after 4 weeks of treatment. Additional measurements include gastric emptying, overall gastrointestinal quality of life, aspiration symptoms, microbiome analysis, pneumonia occurrences, and esophageal reflux events at various points up to 10 weeks. Safety and effectiveness of the treatments will be monitored throughout the study period.

Gastrointestinal Dysmotility on Aspiration Risk