This trial is active, not recruiting.

Condition gastroesophageal reflux
Sponsor Massachusetts General Hospital
Collaborator Takeda Pharmaceuticals North America, Inc.
Start date September 2004
End date June 2010
Trial size 100 participants
Trial identifier NCT01048840, 2007-P-000907, TAP-PediGERD


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
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.
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

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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

Additional Information

Official title The Natural History of Children With Gastroesophageal Reflux Disease (Ages 15 Months to 11 Years)
Principal investigator Harland S Winter, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.