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Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Harland S. Winter, MD, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181805
First Posted: September 16, 2005
Last Update Posted: October 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Harland S. Winter, MD, Massachusetts General Hospital
  Purpose
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.

Condition
Gastroesophageal Reflux

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Natural History of Children With Persistent Gastroesophageal Reflux Disease (Ages 12 to 17 Years)

Resource links provided by NLM:


Further study details as provided by Harland S. Winter, MD, Massachusetts General Hospital:

Estimated Enrollment: 25
Study Start Date: September 2004
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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:

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181805


Locations
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
AstraZeneca
Investigators
Principal Investigator: Harland S. Winter, MD Massachusetts General Hospital
  More Information

Responsible Party: Harland S. Winter, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181805     History of Changes
Other Study ID Numbers: AZ-PediGERD
2007-P-000906
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: October 24, 2013
Last Verified: October 2013

Keywords provided by Harland S. Winter, MD, Massachusetts General Hospital:
GER

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases