Gastro Esophageal RefluxNCT05180253
Esophageal and Gastric Registry and Biorepository
An observational study of Gastro Esophageal Reflux, run by University of Louisville at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- Esophageal studies
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Norton Healthcare
Louisville, Kentucky, 40202
Benjamin Rogers, 502-852-6991, benjamin.rogers@louisville.edu
About this study
Official title: 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.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- Esophageal studies
- Keywords
- Mucosal Integrity, Functional Luminal Imaging Probe
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal studiesDiagnostic test
Healthy subjects will undergo esophageal and blood testing.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Not described Receives: Diagnostic Test: Esophageal studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normative mucosal integrity values
We will establish the range of MI values in healthy, asymptomatic individuals.
Measured: 1 year
Normative pyloric FLIP values
We will further establish the range of FLIP values that can be seen in healthy, asymptomatic individuals.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start9 Jan 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin D Rogers, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180253
- Sponsor's protocol ID
- 20.0990
- Status last verified
- Apr 2026
- First submitted
- 28 Oct 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Control Esophageal and Gastric Registry and Biorepository
- ClinicalTrials.gov ID
- NCT05180253
- Acronym / sponsor ID
- 20.0990
- Conditions
- Gastro Esophageal Reflux
- Keywords
- Mucosal Integrity, Functional Luminal Imaging Probe
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Diagnostic Test: Esophageal studies |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (8 listed)
- Minors
- Surgeries involving the GI tract
- Medication use affecting acid secretion or gut motility
- Personal history of malignancy
- Mental health issues precluding informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal studiesHealthy subjects will undergo esophageal and blood testing. | Diagnostic test | Healthy Subjects |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro Esophageal Reflux, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative mucosal integrity values (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.