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

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Gastroesophageal Reflux

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01048840
TAP-PediGERD
2007-P-000907

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

100 participants in 2 patient groups

Subject with History of GERD
Description:
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
Description:
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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