Esophageal and Gastric Registry and Biorepository

The evaluation of the foregut, the esophagus and stomach, has come a long way over the past two decades, and continues to experience exciting discoveries in the clinical evaluation of foregut physiology. Assessing esophageal peristalsis has relied for the past several decades on High Resolution Manometry (HRM), however it has recently become known that even though HRM is an extremely effective tool, that there are certain subsets of patients in which additional information is required. Additionally, the assessment of esophageal reflux disease has relied on pH impedance for the last two decades. However, this procedure requires a catheter to be passed through a nostril and remain in place for at least 24 hours. Novel techniques, already FDA approved, including EndoFLIP for esophageal peristalsis and mucosal integrity (MI) for reflux disease, have emerged as time-of-endoscopy assessments. Both involve the placement of a balloon through the scope at time of upper endoscopy (standard first line assessment for both dysphagia and reflux symptoms) and are quick and pose little-to-no additional risk or discomfort for patients. However, data regarding normal esophageal parameters are poorly defined for both EndoFLIP and MI. Additionally, EndoFLIP has increasingly been used to assess the pylorus, and scarce data exists there regarding how a tool originally envisioned for esophageal assessment can be used more distally in the GI tract.

We will recruit healthy, asymptomatic volunteers to undergo testing with MI and FLIP (esophageal and pyloric). The data obtained will help establish the benchmark from which assessments can be made in patients.

Recruiting

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Key information

Conditions

Gastro Esophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Norton Healthcare

Louisville, Kentucky, 40202, United States

Location status: Recruiting

Location contact

Benjamin Rogers

CONTACT

[email protected]

502-852-6991

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophageal studies

Diagnostic Test

Healthy subjects will undergo esophageal and blood testing.

Primary outcomes

Normative mucosal integrity values

Time frame: 1 year

We will establish the range of MI values in healthy, asymptomatic individuals.
Normative pyloric FLIP values

Time frame: 1 year

We will further establish the range of FLIP values that can be seen in healthy, asymptomatic individuals.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Healthy Control Esophageal and Gastric Registry and Biorepository

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Jan 6, 2022
Registry last updated: May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting