Pediatric Alliance for International Neurogastrointestinal Functional Research

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

348 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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FAP IBS

No interventions assigned to this group

Eligibility Criteria

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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.)

Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No