In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter

February 20, 2019 updated by: Larry Miller, Northwell Health

The purpose of this study is:

  • To study the components of the gastroesophageal junction high-pressure zone individually and as a group, by pharmacologically eliminating or accentuating the pressure profile generated by the smooth muscle components.
  • To differentiate the gastric sling fibers from the clasp fibers based on the spatial orientation of these muscle groups.

Study Overview

Status

Terminated

Conditions

Detailed Description

The purpose of this research study is to examine and evaluate a part of the digestive system (gastrointestinal tract). The specific part the study team will look at is called the "lower esophageal sphincter complex." This complex is located where the esophagus (food pipe) meets the top of the stomach. The lower esophageal sphincter complex involves a group of muscles, and the study team hopes to better understand how they work.

The study team hopes that, by studying the lower esophageal sphincter complex, it may be possible to discover how it functions and what causes it to fail. When a complex fails, this can lead to reflux and heartburn. So learning more about the lower esophageal complex may help doctors' better treat future patients with reflux problems.

We plan to study these functions in normal control subjects, in patients with GERD (heartburn symptoms), and in patients with Barrett's esophagus (a change in the lining of the esophagus due to chronic reflux). The doctor performing the study procedure has previous experience with and is skilled in performing these procedures.

Study Type

Observational

Enrollment (Actual)

4

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

  • United States
    • New York
      • New Hyde Park, New York, United States, 11040
        • LIJ Medical Center- NSLIJ Health System

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Normal control subjects without GERD and patients with GERD

Description

Inclusion Criteria:

Inclusion criteria for GERD patients are:

  • Symptomatic heartburn
  • Regurgitation
  • Chest pain or water brash

Exclusion Criteria:

Exclusion criteria for normal volunteers include:

  • Medications-Subjects on any medication which could effect the gastroesophageal junction high-pressure zone will be excluded, this includes use of antacids, H2 blockers, proton pump inhibitors, prokinetic agents, erythromycin type antibiotics and anticholinergics.
  • GI symptoms, conditions and disorders

In addition exclusion criteria will include a history of:

  • Esophagitis
  • Gastrointestinal symptoms such as abdominal pain
  • Heartburn
  • Reflux
  • Regurgitation
  • Chest pain
  • Difficulty swallowing
  • Pain on swallowing
  • Dysphagia
  • Abdominal surgery involving the stomach or esophagus
  • Nausea or vomiting
  • Diabetes
  • Scleroderma
  • Esophageal motility disorders
  • Non cardiac chest pain
  • Achalasia and current pregnancy.

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
Normal Control
Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD
GERD Patients
GERD patients are those with history of GERD, signs and symptoms of GERD and selected signs and symptoms of GERD in the questionnaire.
Barrett's patients
Barrett's patients are those participants who in addition to all the qualities of GERD patients have long standing history of GERD and mucosal changes in the esophagus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure at the gastric sling and clasp fibers
Time Frame: 5 years
esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers
5 years

Collaborators and Investigators

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

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Larry S Miller, MD, Feinstein Institute for Medical Research

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)

April 12, 2013

Primary Completion (Actual)

April 9, 2015

Study Completion (Actual)

February 3, 2017

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DK059500 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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