Esophageal and Gastric Registry and Biorepository

Launched by UNIVERSITY OF LOUISVILLE · Dec 31, 2021

Keywords

ClinConnect Summary

The Esophageal and Gastric Registry and Biorepository trial is studying new methods to better understand how the esophagus and stomach work, particularly in patients with gastroesophageal reflux disease (GERD). Researchers want to gather information from healthy volunteers to set a "normal" standard that can help evaluate patients with related symptoms. They will be using two new FDA-approved tests that are quick and comfortable, involving the use of a balloon during a routine endoscopy to assess how well the esophagus and stomach are functioning.

To be eligible for this trial, participants should be between 18 and 85 years old, have no prior surgeries on their digestive system, and must not currently have any symptoms related to their stomach or esophagus. They should also not be taking medications that affect stomach acid or digestion. Participants will undergo testing without significant discomfort, and their contributions will help improve future assessments for patients experiencing esophageal and gastric issues. It's important to know that the study excludes individuals with certain medical histories or conditions, including those who are pregnant or nursing.

Gender

ALL

Eligibility 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