Status:
UNKNOWN
Identification Genetic, Immunologic and Microbial Markers of Hirschsprung Associated Enterocolitis in Children With Hirschsprung Disease
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Karolinska University Hospital
Children's Hospital Los Angeles
Conditions:
Hirschsprung Disease
Enterocolitis
Eligibility:
All Genders
1-17 years
Brief Summary
To identify demographic, clinical, genetic, immunologic and/or microbial (i.e., fecal stream characterization) risk factors that influence the likelihood of development of the HAEC phenotype in childr...
Detailed Description
Emerging data suggests that the distinct phenotype of HAEC in children with HD may be the result of the complex interplay between host genetics, immune response and environmental triggers. Data sugges...
Eligibility Criteria
Inclusion
- 1\. Males and females of all ages with a confirmed diagnosis of HD based on standardized histological criteria. Only Males and females ages 0 to 17 with a confirmed diagnosis of HD based on standardized histological criteria will be enrolled at CSMC.
- 2\. Able to provide written informed assent if between the ages of 7 and 17. If age 6 and under, able to participate with parental permission.
- 3\. Have consented to have specimens tested for genetics, immune responses, stool microflora.
- Case Ascertainment:
- All patients with a confirmed diagnosis of HD are eligible for enrollment. A diagnosis of HD for this study will require:
- 1)Documented histopathology showing absence of ganglion cells and is consistent with the diagnosis of HD.
Exclusion
- 1\. Intestinal neuronal dysplasia
- 2\. Pseudo-obstruction
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02193685
Start Date
February 1 2010
End Date
December 1 2025
Last Update
August 12 2016
Active Locations (1)
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1
Cedars-Sinai Medical Center 8723 Alden Drive, Suite 240
Los Angeles, California, United States, 90048