Gastroparesis Registry 3 — GpR3  

Gastroparesis Clinical Trial

Official title: The NIDDK Gastroparesis Registry 3: Characterization and Clinical Course of Symptoms and Gastric Emptying in Patients With Symptoms of Gastroparesis

Status Completed

Clinical Trial Summary

The purpose of this study is to create a new registry of patients with gastroparesis in order to better understand the characteristics of patients with gastroparesis and follow how their condition changes over time. The data collected may improve the understanding of the condition to enable better diagnosis and treatment.

Clinical Trial Description

GpR 3 is an observational study of patients with symptoms of gastroparesis with either delayed or normal gastric emptying. Epidemiological, clinical, physiological, and patient outcome data will be 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.

The primary objectives of the Gastroparesis Registry 3 (GpR 3) are:

• To create a new registry of patients with symptoms of gastroparesis, both patients with delayed gastric emptying and patients with similar symptoms but normal gastric emptying, for the enhanced study of symptoms, gastric motility abnormalities, patient characteristics, and degree of morbidity.

• To follow a well-characterized cohort to further define the natural history and clinical course of patients with symptoms of gastroparesis - both symptoms and gastric emptying over time. Treatments given for their clinical care and clinical responses to treatments will be recorded.

• To provide a reliable source for recruitment of well-characterized patients with gastroparesis for other studies including therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies. These subsequent clinical trials or ancillary studies will be conducted under separate study protocols with separate consent processes.

Specific secondary objectives of GpR3 have been developed to allow the patients entered in GpR3 to help advance our understanding of gastroparesis:

• Assess several areas of gastric motility in patients with symptoms of gastroparesis (fundic accommodation, antral contractility, global gastric emptying).

• Determine the change in gastric motility over time, in patients with gastroparesis and in patients with symptoms of gastroparesis but normal gastric emptying.

• Evaluate the clinical symptomatic course (outcome) of patients followed in the registry.

• Use the registry to better capture clinical treatment responses to specific treatments while patients are in the registry.

• Characterize abdominal pain in patients with gastroparesis and gastroparesis-like syndrome by:

• Describing the abdominal pain seen in patients with gastroparesis

• Determining if the pain has neuropathic or nociceptive qualities

• Determining attributes of patients with abdominal pain

• Assessing patients in the presence of sensory gastric dysfunction

• Objective mapping of the abdominal pain and determining central and/or peripheral attributes of the abdominal pain

• Compare the Rome IV categories of gastric disorders (functional dyspepsia (FD), epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), chronic idiopathic nausea and vomiting (CINV), rumination syndrome, cyclic vomiting syndrome, central abdominal pain syndrome) to our present classification of gastroparesis and gastroparesis-like disorder.

• Determine the prevalence of hypermobility spectrum disorders (HSD) in patients with gastroparesis.

• Compare the water load satiety test (WLST) to intragastric meal distribution (IMD) during scintigraphy and to symptoms of early satiety, postprandial fullness in patients with symptoms of gastroparesis.

• Collect serum, plasma, and peripheral blood mononuclear cells (PBMC) that can be used for subsequent analysis to address specific research questions. ;

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis
• Idiopathic Gastroparesis

• NCT number: NCT03680859
• Study type: Observational
• Source: Johns Hopkins Bloomberg School of Public Health
• Status: Completed
• Start date: January 24, 2019
• Completion date: May 13, 2024