Pediatric Gastroparesis Registry 2 Study (PGpR2) supplement

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

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Abstract

PGpR2 ABSTRACT Study Overview: Title: The GpCRC Pediatric Gastroparesis Registry 2 (PGpR2): Characterization and Clinical Course of Symptoms and Gastric Emptying in Pediatric, Adolescent, and Young Adult Participants with Symptoms of Gastroparesis Study Purpose: This observational, multi-center, prospective Registry study is designed to delineate the clinical trajectory of pediatric, adolescent, and young adult patients (ages 8–25) exhibiting symptoms indicative of gastroparesis (Gp), such as nausea, vomiting, early satiety, bloating, and abdominal pain, irrespective of gastric emptying status. This study is anticipated to take up to 3 years. Study Aims: • Primary Objective: To document the demographic, clinical, and symptom profiles, as well as the overall morbidity and progression of illness over time, in participants with symptoms of Gp. • Secondary Objective: To evaluate and compare clinical, physiological, and psychological differences between participants with confirmed delayed gastric emptying (gastroparesis) and those with Gp-like syndrome (GLS) but normal gastric emptying. Methods: The PGpR2 study has established a national Registry collecting standardized demographic, clinical, physiological, and patient-reported outcome measures. GP-specific symptom severity and quality of life are assessed longitudinally over a 48-week period using the Pediatric GI Symptom Index (Including BARF Retching Scale), Rome IV Diagnostic Questionnaire for Pediatrics FGIDs and PedsQL™ 3.0 Gastrointestinal Symptoms Scales™, the primary outcome tool. Study Leadership and Scope: Baylor College of Medicine / Texas Children’s Hospital is serving as the coordinating center. A total of 216 participants will be enrolled over a three-year recruitment period across six academic sites participating in the NIH/NIDDK Gastroparesis Clinical Research Consortium. The full duration of the study is five years, which includes recruitment, follow-up (up to three years per participant), and data analysis.