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Gastric Accommodation and Gastroesophageal Reflux

Sponsor
Nationwide Children's Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01078064
Collaborator
(none)
10
Enrollment
1
Location
8
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    10 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
    Actual Study Start Date :
    Mar 1, 2010
    Actual Primary Completion Date :
    Nov 1, 2010
    Actual Study Completion Date :
    Nov 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Study group

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Nationwide Children's Hospital Columbus Ohio United States 43205

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rodrigo Strehl Machado, MD, PhD, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT01078064
    Other Study ID Numbers:
    • 001-2010
    First Posted:
    Mar 2, 2010
    Last Update Posted:
    Mar 21, 2019
    Last Verified:
    Mar 1, 2019
    Keywords provided by Rodrigo Strehl Machado, MD, PhD, Nationwide Children's Hospital
    Gastroesophageal reflux disease, gastric motility
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esophagitis, Peptic

    Study Results

    No Results Posted as of Mar 21, 2019