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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00181805
Collaborator
AstraZeneca (Industry)
25
Enrollment
1
Location
123
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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 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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    25 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    The Natural History of Children With Persistent Gastroesophageal Reflux Disease (Ages 12 to 17 Years)
    Actual Study Start Date :
    Sep 1, 2004
    Actual Primary Completion Date :
    Jun 1, 2010
    Actual Study Completion Date :
    Dec 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years to 50 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Harland S. Winter, MD, Principal Investigator, Massachusetts General Hospital
      ClinicalTrials.gov Identifier:
      NCT00181805
      Other Study ID Numbers:
      • AZ-PediGERD
      • 2007-P-000906
      First Posted:
      Sep 16, 2005
      Last Update Posted:
      Dec 2, 2020
      Last Verified:
      Nov 1, 2020
      Keywords provided by Harland S. Winter, MD, Principal Investigator, Massachusetts General Hospital
      GER
      Additional relevant MeSH terms:
      Gastroesophageal Reflux
      Esophagitis, Peptic

      Study Results

      No Results Posted as of Dec 2, 2020