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

NCT01048840 | Completed

• 2 other identifiers: TAP-PediGERD2007-P-000907
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux

Study Arms (2)

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.

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The subjects will be selected from a database of patients seen at Children's Hospital, Boston or Massachusetts General Hospital between 1977 and 1990 who had biopsies or pH probe for symptoms of GERD.

You may qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

Children's Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Harland S Winter, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: September 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2014
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

US (1)