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NCT01099787 Clinical Trial

Pediatric Alliance for International Neurogastrointestinal Functional Research

Irritable Bowel Syndrome Clinical Trial

Official title:
Pediatric Alliance for International Neurogastrointestinal Functional Research Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01099787
Other study ID # IRB10-00022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2010
Est. completion date June 2017

Study information
Verified date July 2018
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 348
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 4 Years to 16 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Emma Children's Hospital Amsterdam
United States Children's Hospital Boston Boston Massachusetts
United States Childrens Memorial Hospital Chicago Illinois
United States Nationwide Children's Hospital Columbus Ohio
United States Connecticut Children's Hospital Hartford Connecticut
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States LSU Health Sciences Center New Orleans Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Nationwide Children's Hospital

Countries where clinical trial is conducted

United States,  Netherlands, 

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