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OpenTrials
Completed

NCT Number: NCT01048840

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Takeda Pharmaceuticals North America, Inc.

Registry information

Official study title

The Natural History of Children With Gastroesophageal Reflux Disease (Ages 15 Months to 11 Years)

Important dates

Study start
2004
Primary completion
2010
Study completion
2014
First posted
Jan 14, 2010
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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