Longitudinal database for patients with gastroparesis symptoms
Gastroparesis Outcome Longitudinal Database Enrolled Numerically
This study is tracking patients with gastroparesis symptoms over time to see how their health and quality of life change, regardless of the treatments they receive.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Drugs / interventions | Immunotherapy |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT03876288 on ClinicalTrials.gov |
What this trial studies
The GOLDEN project is a longitudinal database that tracks patients with symptoms of gastroparesis at the University of Louisville, starting from 2012 and continuing to the present. It includes both current patients and legacy patients from other centers, allowing for comprehensive data collection on symptoms, survival, quality of life, and various health measures over time. The study evaluates outcomes regardless of treatment and stratifies results based on different interventions, including GI neuromodulation and immunotherapy. This extensive data collection aims to provide insights into the management and effects of gastroparesis.
Who should consider this trial
Good fit: Ideal candidates are patients with drug-refractory gastroparesis symptoms and disordered nutrition.
Not a fit: Patients with anatomic obstruction of the GI tract or psychiatric disorders that hinder assessment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of gastroparesis and improve patient management strategies.
How similar studies have performed: Other studies have shown success in tracking outcomes for chronic gastrointestinal conditions, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Louisville, Kentucky
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Abell, MD — University of Louisville
- Study coordinator: Thomas Abell, MD
- Email: thomas.abell@louisville.edu
- Phone: (502)852-6991
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.