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

GERD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737802
• Other study ID #: R01DK059500
• Status: Terminated
• Start date: April 12, 2013
• Est. completion date: February 3, 2017

Study information

• Verified date: February 2019
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 3, 2017
• Est. primary completion date: April 9, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barretts Esophagus
• GERD

Locations

Country	Name	City	State
United States	LIJ Medical Center- NSLIJ Health System	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure at the gastric sling and clasp fibers	esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers	5 years