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Gastric Accommodation and Gastroesophageal Reflux

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ClinicalTrials.gov Identifier: NCT01078064
Recruitment Status : Unknown
Verified February 2010 by Nationwide Children's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 2, 2010
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
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.

Condition or disease
Gastroesophageal Reflux Disease

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
Estimated Enrollment : 33 participants
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
Study Start Date : March 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rodrigo Strehl Machado, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01078064     History of Changes
Other Study ID Numbers: 001-2010
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: February 2010

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