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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048840
• Other study ID #: TAP-PediGERD
• Secondary ID: 2007-P-000907
• Status: Completed
• Start date: September 2004
• Est. completion date: December 2014

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux

Locations

Country	Name	City	State
United States	Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States,