Actively Recruiting
Healthy Control Esophageal and Gastric Registry and Biorepository
Led by University of Louisville · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the foregut, including the esophagus and stomach, to improve clinical evaluation methods for foregut physiology. This observational study focuses on healthy, asymptomatic volunteers to gather data on esophageal peristalsis and reflux disease using new diagnostic tools. These tools, EndoFLIP and mucosal integrity (MI) assessments, are performed during upper endoscopy and aim to provide quick, less uncomfortable alternatives to traditional methods. The study is sponsored by the University of Louisville and targets establishing normal reference values for these assessments. Participants will undergo esophageal and pyloric testing using EndoFLIP and MI during standard upper endoscopy procedures. These tests involve a balloon placed through the endoscope to assess esophageal and pyloric function and mucosal integrity without additional significant risk or discomfort. The study will collect diagnostic data and blood samples from healthy subjects to help define normal esophageal and gastric parameters. During the study, participants will complete gastroesophageal and gastric symptom questionnaires to confirm their asymptomatic status. Researchers will measure normative mucosal integrity and pyloric FLIP values over one year. The study excludes participants with prior gastrointestinal surgery, certain medical conditions, or medication use that could affect results. Participation involves one-time testing during endoscopy, with data collection focused on establishing benchmarks for future patient assessments.
CONDITIONS
Brief Title
Esophageal and Gastric Registry and Biorepository
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- No prior surgical history
- Asymptomatic on gastroesophageal and gastric symptom questionnaires
- Not currently taking medications affecting acid secretion or gut motility
- No history of malignancy
- No mental health issues affecting informed consent
- No history of smoking
- No excessive or daily alcohol use
- BMI under 30
- No known hiatus hernia
- No known medical illnesses like autoimmune or neurological conditions affecting esophageal or gastric function
- Not allergic to fentanyl or versed
- No history of eating disorders
- No history of autoimmune disorders
You will not qualify if you...
- Under 18 years of age
- Previous surgeries involving the gastrointestinal tract
- Use of medications affecting acid secretion or gut motility
- Personal history of malignancy
- Mental health issues preventing informed consent
- Presence of symptoms on standard clinical questionnaires
- Pregnant women
- Nursing women due to medication effects and procedure time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo esophageal and blood testing to collect diagnostic data.
1 visit (in-person)
Duration - 1 year
Participants are observed to establish normative values over one year.
Follow-up assessments may occur depending on study procedures
Trial Site Locations
Total: 1 location
1
Norton Healthcare
Louisville, Kentucky, United States, 40202
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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