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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01779154
Other study ID # 136132
Secondary ID
Status Withdrawn
Phase N/A
First received January 28, 2013
Last updated June 16, 2016
Start date January 2013
Est. completion date May 2017

Study information

Verified date June 2016
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

The Eosinophilic Gastrointestinal Disorders (EGIDS) Registry is a longitudinal study that does not involve medical interventions, but serves as a record of demographics, characteristics of disease and treatment, utilization patterns, quality improvement measures and clinical outcomes. The database is proposed so that epidemiologic research can be performed and current and accurate data can be obtained regarding practice patterns, age and gender distributions, efficacy of treatment, clinical outcomes and changes in quality of life.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2017
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- male or female participants of any race or ethnicity

- age 0 to 21 years

- diagnosis of EGID including: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis

Exclusion Criteria:

- hypereosinophilic syndrome

- non-eosinophilic gastrointestinal or allergic disorder

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Arkansas Children's Hospital Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To define characteristics of an eosinophilic gastrointestinal disorder population in a rural southern state To develop a database of patients with eosinophilic gastrointestinal disorders so that epidemiologic research can be performed and current data can be obtained regarding practice patterns, age and gender distributions, efficacy of treatment, clinical outcomes and changes in quality of life. After 12 months of data collection No
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