Pediatric Alliance for International Neurogastrointestinal Functional Research
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Purpose
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.
| Condition |
|---|
|
Irritable Bowel Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Pediatric Alliance for International Neurogastrointestinal Functional Research Registry |
Eligibility| Ages Eligible for Study: | 4 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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.)
Contacts and Locations| Contact: Stacy Ballam, M.A. | 614-722-3004 | stacy.ballam@nationwidechildrens.org |
| United States, Connecticut | |
| Connecticut Children's Hospital | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Jeffrey Hyams, MD 860-545-2571 jhyams@ccmckids.org | |
| Contact: Heidi Sweeney, MSN 860-545-9560 Hsweene@ccmckids.org | |
| Principal Investigator: Jeffrey Hyams, MD | |
| United States, Illinois | |
| Childrens Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Miguel Saps, MD 224-625-2180 Msaps@childrensmemorial.org | |
| Contact: Papa Adams 773-975-8859 PAdams@childrensmemorial.org | |
| Principal Investigator: Miguel Saps, MD | |
| United States, Louisiana | |
| LSU Health Sciences Center | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Contact: Paul Hyman, MD 504-899-9511 PaulHyman@aol.com | |
| Contact: Carrie Firestone-Baum, MD 504-432-8586 cfire1@lsuhsc.edu | |
| Principal Investigator: Paul Hyman, MD | |
| United States, Massachusetts | |
| Children's Hospital Boston | Completed |
| Boston, Massachusetts, United States, 02115 | |
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Stacy Ballam 614-722-3004 | |
| Contact: Beth Skaggs 614-722-3487 | |
| Principal Investigator: Carlo Di Lorenzo, M.D. | |
| United States, Wisconsin | |
| Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Manu Sood, MD 414-266-6974 Msood@mcw.edu | |
| Contact: Christina Gorges 414.266.6131 cgorges@mcw.edu | |
| Principal Investigator: Manu Sood, MD | |
| Netherlands | |
| Emma Children's Hospital | Not yet recruiting |
| Amsterdam, Netherlands | |
| Contact: Marc Benninga, MD 0031-20-5663053 M.A.Benninga@amc.uva.nl | |
| Principal Investigator: Marc Benninga, MD | |
| Principal Investigator: | Carlo Di Lorenzo, M.D. | Nationwide Children's Hospital |
More Information
No publications provided
| Responsible Party: | Dr. Carlo Di Lorenzo, Nationwide Children's Hospita; |
| ClinicalTrials.gov Identifier: | NCT01099787 History of Changes |
| Other Study ID Numbers: | IRB10-00022 |
| Study First Received: | April 7, 2010 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
