Characterization and Clinical Course of Symptoms and Gastric Emptying in Pediatric Participants with Symptoms of Gastroparesis

Texas Tech University Health Sciences Center At El Paso, El Paso TX

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Abstract

Summary/ Abstract of Parent Award Title: The NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) Gastroparesis Registry 3: Characterization and Clinical Course of Symptoms and Gastric Emptying in Patients with Symptoms of Gastroparesis Background: The NIH GpCRC has generated an extensive number of gastroparesis (GP) related studies, which have increased our knowledge and concepts of understanding of this condition, its complications, diagnostic challenges and clinical outcomes. The most current study was called The Gastroparesis Registry 3 (GpR 3), which now is recognized as a Parent Project/Award (Federal Identifier: DK74035). Objectives of GpR3 are: 1) To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis. 2) To continue to follow and expand the data collections 3) To provide a reliable source for recruitment of well-characterized patients with GP for therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies. Methods: We enrolled diabetic, idiopathic and post-Nissen fundoplication gastroparesis patients with delayed and normal gastric emptying. TTUHSC EP was able to enrolled 104 out of 400 participating subjects. Baseline data collection included demographic, socioeconomic characteristics and all measures capturing information requested by the protocol. In 2020 COVID-19 study was implemented to assess whether COVID-19 is associated with development of post-infection GP. Results: The parent project, Gastroparesis Registry 3 (GpR3), is still an active study that collects data from qualified and already enrolled patients with symptoms of and like- gastroparesis. Epidemiological, clinical, physiological, and patient outcome data is being collected to characterize the patients and their clinical course to better understand this disorder. The long-term goal is to help phenotype patients into pathophysiologically defined subsets. This classification will provide a foundation for translational research, facilitating the search for etiopathogenesis and enhance the ability to define and conduct large clinical trials, ultimately leading to the development of more rational and effective therapeutic approaches for gastroparesis. GpR3 recruited patients who are 18 years of age and older. The new sub-project, The Pediatric Gastroparesis Registry2 (PGpR2), aims to assess the same objectives in patients between the ages of 8 and 24 years old, who are seen in the pediatric GI multicenter clinics. Specifics on this pediatric study are presented in an attached grant application, which designated PI/PDs Dr. McCallum and Dr Sarosiek as supervisors and mentors responsible for the advisory role and outcomes of Dr Francis, Pediatric GI PI, and conduct of the study.