Natural History of Gastroesophageal Reflux (GER) in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux

Keywords

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Gastroesophageal Reflux

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Harland S. Winter, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harland S Winter, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2007-P-000907

Identifier Type: -

Identifier Source: secondary_id

TAP-PediGERD