Gastric Accommodation and Gastroesophageal Reflux

March 19, 2019 updated by: Rodrigo Strehl Machado, Nationwide Children's Hospital

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

10

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
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

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

1 year to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD symptoms, such as epigastric pain, respiratory symptoms, heartburn, feeding difficulties, chest pain, nausea or vomiting.

Description

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 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
Study group
Patients with symptoms suggesting gastroesophageal reflux and referred to perform an impedance study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NUMBER OF REFLUX EPISODES
Time Frame: 1 day
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 Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Rodrigo S Machado, MD, PhD, Nationwide Children's Hospital
  • Study Director: Beth Skaggs, CCRC, Nationwide Children's Hospital

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)

March 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (ESTIMATE)

March 2, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-2010

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.

Clinical Trials on Gastroesophageal Reflux Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe