Pediatric Alliance for International Neurogastrointestinal Functional Research

Pediatric Alliance for International Neurogastrointestinal Functional Research Registry

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome

• Study Type: Observational
• Enrollment (Actual): 348

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Emma Children's Hospital
• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Hospital
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Childrens Memorial Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • LSU Health Sciences Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients ages 4 through 16 years of age (up to the day of the 17th birthday) will be recruited from the Nationwide Children's Hospital Gastrointestinal Department that are presenting with chronic or intermittent abdominal pain of any severity lasting at least 2 months.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
FAP IBS

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Investigators: Principal Investigator: Carlo Di Lorenzo, M.D., Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (Estimate): April 8, 2010

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: IRB10-00022