Esophageal and Gastric Registry and Biorepository

April 28, 2026 updated by: Benjamin D Rogers, University of Louisville

Healthy Control 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults 18-85 years of age, free of esophageal symptoms, never diagnosed with esophageal disorders, never diagnosed with an autoimmune disease, able to provide informed consent, and willing and able to undergo esophageal physiologic studies and biopsies.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Subjects
Diagnostic test: Esophageal studies
Healthy subjects will undergo esophageal and blood testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normative mucosal integrity values
Time Frame: 1 year
We will establish the range of MI values in healthy, asymptomatic individuals.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

December 31, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.0990

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastro Esophageal Reflux

Clinical Trials on Esophageal studies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe