Gastric Accommodation and Gastroesophageal Reflux

Terminated

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT01078064
• Lead Sponsor: Nationwide Children's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-02-25
• Study Start: 2010-03
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NUMBER OF REFLUX EPISODES	1 day	It is a cross-sectional exam, and the number of reflux episodes at baseline, after a clinically indicated 24-hour impedance study

Secondary Outcome Measures

Name	Time	Method
Gastric volume ratio: 10 min/baseline	1 day	It is a cross-sectional study. This variable will be assessed by ultrasound in the next morning of the impedance study.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States