Gastric Accommodation and Gastroesophageal Reflux

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Gastric Accommodation as a Factor Influencing the Number of Reflux Episodes in Children and Adolescents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01078064
• Other study ID #: 001-2010
• Status: Terminated
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: March 2019
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Gastroesophageal reflux events generally happen during relaxation of lower esophageal sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead to reflux events. To test this hypothesis, a study was designed to measure the gastric accommodation in patients undergoing esophageal impedance monitoring.

Description:

Gastroesophageal reflux events happen during relaxations of lower esophageal sphincter not related to swallowing, called transient. These transient lower esophageal sphincter relaxations (tLESR) are generally triggered by gastric distension and its physiological purpose is to vent the stomach. The gastric accommodation is a physiological process in which the gastric fundus actively relaxes during a meal in order to accommodate it.

This study is driven by the hypothesis that impairment of the gastric accommodation may facilitate triggering tLESR and, therefore, reflux events. We aim to evaluate the relation between gastric fundic relaxation and the number of gastroesophageal reflux events in children. We also aim to evaluate if there is a relation between the gastric emptying and the number of reflux episodes.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 30 Years

Eligibility

Inclusion Criteria:

• children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD* symptoms

Exclusion Criteria:

• continuous feeding

• previous fundoplication

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NUMBER OF REFLUX EPISODES	It is a cross-sectional exam, and the number of reflux episodes at baseline, after a clinically indicated 24-hour impedance study	1 day
Secondary	Gastric volume ratio: 10 min/baseline	It is a cross-sectional study. This variable will be assessed by ultrasound in the next morning of the impedance study.	1 day