Registry and biorepository for esophageal and gastric conditions
Healthy Control Esophageal and Gastric Registry and Biorepository
This study is trying to learn more about how the esophagus and stomach work in people with gastroesophageal reflux disease by using new testing methods and collecting samples to improve diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT05180253 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the esophagus and stomach using novel techniques such as EndoFLIP and mucosal integrity assessments during upper endoscopy. It focuses on patients with gastroesophageal reflux disease, providing a more comprehensive understanding of esophageal peristalsis and reflux mechanisms. The study will collect data and biological samples to enhance the understanding of foregut physiology and improve diagnostic methods. Participants will undergo esophageal studies without prior surgical history or current medications affecting gut motility.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with no prior surgical history and asymptomatic according to gastroesophageal and gastric questionnaires.
Not a fit: Patients with a history of malignancy, significant gastrointestinal surgeries, or those currently taking medications affecting acid secretion or gut motility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic techniques for gastroesophageal reflux disease, enhancing patient care.
How similar studies have performed: While this approach utilizes established techniques, the specific combination of assessments in this registry is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-85 * No prior surgical history * Asymptomatic according to gastroesophageal and gastric questionnaires * Not currently taking any medications that affect acid secretion or gut motility * No history of malignancy * No mental health issues precluding informed consent * No smoking history * No excessive or daily alcohol use * BMI \< 30 * No known hiatus hernia * No known medical illness (autoimmune, neurological) that could be associated with altered esophageal or gastric function * Not allergic to fentanyl or versed * No history of eating disorder * No history of autoimmune disorders Exclusion Criteria: * Minors * Surgeries involving the GI tract * Medication use affecting acid secretion or gut motility * Personal history of malignancy * Mental health issues precluding informed consent * Symptoms on standard clinical questionnaires * Pregnant - the effect that pregnancy has on esophageal and gastric motility is not well defined, but we will need to eliminate this as a confounding factor * Nursing women - although the investigations are FDA approved and part of standard clinic practices, they are time consuming and involve medication administration that might affect the ability of a mother to nurse
Where this trial is running
Louisville, Kentucky
- Norton Healthcare — Louisville, Kentucky, United States (Recruiting)
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.