Gastroparesis Outcome Longitudinal Database Enrolled Numerically

Gastroparesis Clinical Trial

— GOLDEN  

Official title:

Gastroparesis Outcome Longitudinal Database Enrolled Numerically

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03876288
• Other study ID #: 13.0020
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: University of Louisville
• Contact: Thomas Abell, MD
• Phone: (502)852-6991
• Email: thomas.abell[@]louisville.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

GOLDEN is a longitudinal database of patients with the symptoms (Sx) of gastroparesis (Gp) who were seen and recorded at the University of Louisville from 2012 and is ongoing. Patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of the same team and who are reported as part of the series. Outcome relate to patients Sx, survival, quality of life and other measures as detailed below, over time, regardless of whether any treatment was given or not. If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.

Description:

1. All patients seen with the Sx of Gp and who were evaluated for diagnosis and/or treatment

2. Including legacy patients who were seen and treated at previous locations (Mississippi, Arkansas, Tennessee) before Kentucky if they were part of a clinical research series.

3. Numbers of patients referred or consulted for Gp Sx who were Drug Refractory.

4. Interventions: GI Neuromodulation with gastric electrical stimulation (GES); Immunotherapy with Intravenous Immunoglobulin; Pyloric therapies such as pyloroplasty, surgical or endoscopic.

5. Data for evaluation by: Sx assessments by whatever scales used; Measures of health related quality of life; Psychological and pain assessments; Gastric emptying texts; Electrical measures; Autonomic measure; Serologic measures; Full thickness biopsies; Measures of outpatient & Emergency Room Visits; Measures of hospitalization; Placement of endoscopic or surgical tubes; Radiological and Surgical procedures; Nutritional assessments; If enrolled in any research protocols for data; Stool biome measures; Metabolic measures; Other morbidity measures; Mortality

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion:

• Patients with the symptoms (Sx) of drug refractory gastroparesis

• Disordered nutrition by standardized assessment

• Ability to assess current symptom status

• Ability to measure other medical conditions

Exclusion:

• Anatomic obstruction of the GI Tract

• Pregnancy

• Inability of patient or guardian to sign informed consent, if needed

• Psychiatric disorders precluding assessment and treatment of the patient's GI condition

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Device:
• GI Neuromodulation
The investigators would include follow up with: No treatment; temp GES only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.

Drug:
• Immunotherapy
The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.

Procedure:
• Pyloric Therapies
The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Reported Outcome GI Symptoms	The primary outcome measures are patient symptoms via the traditional gastroparesis patient reported outcome scale. It uses a 0-4 scale from none to worse on GI Symptoms; for example: Nausea,Vomiting, Anorexia/Early Satiety, Bloating/distension, Abdominal Pain. Scored as each item plus a total that is the sum of the individual scales.The five Sx subscales of 0-4 each are summed for a total score range 0-20	Change from baseline to one week to one year