- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00181805
Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
November 30, 2020 updated by: Harland S. Winter, MD, Massachusetts General Hospital
The Natural History of Children With Persistent Gastroesophageal Reflux Disease (Ages 12 to 17 Years)
The goal of this project is to determine the long-term health outcome of children diagnosed with gastroesophageal reflux (GER).
We are inviting subjects that were previously followed in the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston.
We have compiled a database of more than 300 subjects that completed diagnostic testing for GER in the 1970's, 1980's, and 1990's.
Subjects are being contacted initially by mail using a previously approved recruitment letter.
Subjects that fail to respond to this recruitment letter are called by phone.
In each case, contact information has been abstracted from the Children's Hospital database.
Subjects are then given the opportunity to complete a questionnaire either by phone or in hard copy.
Subjects receive no compensation for their participation in this study.
Subjects will be compared to controls.
Controls will complete the same questionnaire as the subjects.
Inclusion of potential controls will be determined by a lack of medical history of gastroenterological diseases before the age of 21 and whether the potential control was born within a year of a subject in the study.
Controls will receive $25 to participate in the study.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The subjects will be selected from a database of patients seen at Children's Hospital, Boston or Massachusetts General Hospital between 1977 and 1990 who had biopsies or pH probe for symptoms of GERD.
Description
Inclusion Criteria for Subjects:
- Patients who were evaluated for GERD at the age of 12-17 years, inclusive at Children's Hospital, Boston or Massachusetts General Hospital
- Positive for GERD per biopsies or pH probe results
Exclusion Criteria for Subjects:
None
Inclusion Criteria for Controls:
- No GI diseases prior to age 21 including, but not limited to reflux, inflammatory bowel disease,Hirschsprung's disease
- Date of birth is within 1 year of a subject's date of birth
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Subject with History of GERD
Children and adolescents ages 12-17 years, inclusive, seen at Children's Hospital, Boston or Massachusetts General Hospital between 1977 and 1990 for symptoms of GERD and also had biopsies and / or a pH probe that was positive for GERD.
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Controls with out GERD
Individuals that do not have a history of GERD or other GI problems prior to age 21 and whose date of birth are with in a year of a subjects
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Harland S. Winter, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2004
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
December 2, 2020
Last Update Submitted That Met QC Criteria
November 30, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZ-PediGERD
- 2007-P-000906
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
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Vanderbilt University Medical CenterCompletedGastroesophageal Reflux Disease (GERD) | Non-erosive Reflux Disease (NERD)United States
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Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedGastroesophageal Reflux Disease (GERD) | RefluxUnited States, Canada