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Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age

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ClinicalTrials.gov Identifier: NCT01048840
Recruitment Status : Unknown
Verified October 2013 by Harland S. Winter, MD, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 14, 2010
Last Update Posted : October 24, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 200 subjects that completed diagnostic testing for GER in the 1970's and 1980'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 or disease
Gastroesophageal Reflux

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Natural History of Children With Gastroesophageal Reflux Disease (Ages 15 Months to 11 Years)
Study Start Date : September 2004
Primary Completion Date : June 2010
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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

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): NCT01048840


Locations
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Takeda Pharmaceuticals North America, Inc.
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: NCT01048840     History of Changes
Other Study ID Numbers: TAP-PediGERD
2007-P-000907
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: October 24, 2013
Last Verified: October 2013

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

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