Pediatric Alliance for International Neurogastrointestinal Functional Research

Nationwide Children's Hospital

Status: Completed

Conditions: Irritable Bowel Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT01099787

IRB10-00022

Details and patient eligibility

About

To explore the predictive value of alarm signs ("red flags") for a diagnosis of functional gastrointestinal disorders (FGID) in children.

To assess the natural history of pain predominant functional gastrointestinal disorders (FGID) in newly diagnosed pediatric patients.

To document the benefit of various treatment regimens currently employed in managing FGID.

To assess the short- and long-term impact of various FGID regimens.

To allow physicians to gain a better understanding of the epidemiology of FGID.

Hypothesis:

There are presenting symptoms or results from diagnostic tests that are more likely to associated with conditions different from FAP or IBS.

Symptoms of children with FAP/IBS change overtime regardless of the treatments used.

Enrollment: 348 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females ages 4 through 16 years of age (up to the day of the 17th birthday)
• Presenting with chronic or intermittent abdominal pain of any severity lasting at least 2 months may participate in the Registry.

Exclusion criteria

• Subjects age 10 and above will be asked to complete the questionnaire themselves. Those unable to complete the questionnaire (with only some help) should not be enrolled.
• Patients unable to participate in the program for at least 3 years should not be enrolled (i.e., anticipated move, etc.)

Trial design

348 participants in 1 patient group

FAP IBS