Gastric Accommodation and Gastroesophageal Reflux

NCT ID: NCT01078064

Last Updated: 2019-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Strehl Machado

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodrigo S Machado, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Beth Skaggs, CCRC

Role: STUDY_DIRECTOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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001-2010

Identifier Type: -

Identifier Source: org_study_id

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