Gastric Accommodation and Gastroesophageal Reflux
Recruitment status was Not yet recruiting
Gastroesophageal Reflux Disease
|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|
- 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
- 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.
|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)|
Patients with symptoms suggesting gastroesophageal reflux and referred to perform an impedance study.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078064
|Contact: Rodrigo S Machado, MD, PhD||622-722-3474||Rodrigo.Machado@NationwideChildrens.org|
|Contact: Beth Skaggs, CCRC||622-722-3474||Beth.Skaggs@nationwidechildrens.org|
|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|
|Principal Investigator:||Rodrigo S Machado, MD, PhD||Nationwide Children's Hospital|
|Study Director:||Beth Skaggs, CCRC||Nationwide Children's Hospital|