Gastric Accommodation and Gastroesophageal Reflux
|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
|Condition or disease|
|Gastroesophageal Reflux Disease|
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|
|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|
Patients with symptoms suggesting gastroesophageal reflux and referred to perform an impedance study.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|