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Gastric Accommodation and Gastroesophageal Reflux

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Nationwide Children's Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01078064
First received: February 25, 2010
Last updated: March 1, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Gastric Accommodation as a Factor Influencing the Number of Reflux Episodes in Children and Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • NUMBER OF REFLUX EPISODES [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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:
  • Gastric volume ratio: 10 min/baseline [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    It is a cross-sectional study. This variable will be assessed by ultrasound in the next morning of the impedance study.


Estimated Enrollment: 33
Study Start Date: March 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study group
Patients with symptoms suggesting gastroesophageal reflux and referred to perform an impedance study.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078064

Contacts
Contact: Rodrigo S Machado, MD, PhD 622-722-3474 Rodrigo.Machado@NationwideChildrens.org
Contact: Beth Skaggs, CCRC 622-722-3474 Beth.Skaggs@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Rodrigo S Machado, MD, PhD     622-722-3474     Rodrigo.Machado@NationwideChildrens.org    
Principal Investigator: Rodrigo S Machado, MD, PhD            
Sub-Investigator: Frederick Woodley, PhD            
Sub-Investigator: Hayat Mousa, MD            
Sub-Investigator: Brian Coley, MD            
Sub-Investigator: Carlo Di Lorenzo, MD            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Rodrigo Strehl Machado, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01078064     History of Changes
Other Study ID Numbers: 001-2010
Study First Received: February 25, 2010
Last Updated: March 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
Gastroesophageal reflux disease, gastric motility

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013