NCT05846802

Gastroparesis Registry 4

Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.

Detailed description

This observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying aims to assess the clinical, pathophysiological, and psychological similarities and differences between patients with Gp, FD. The primary outcome will be the measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.

Conditions

• Gastroparesis
• Gastroparesis Nondiabetic
• Gastroparesis Due to Diabetes Mellitus Type I
• Gastroparesis Due to Diabetes Mellitus Type II
• Functional Disorder of Gastrointestinal Tract
• Gastro-Intestinal Disorder

Timeline

• Start date: 2024-09-20
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2023-05-06
• Last updated: 2026-04-03

Locations

6 sites across 1 country: United States