Text Size

Eosinophilic Gastrointestinal Disorders Patient Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01779154
First received: January 28, 2013
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition
Eosinophilic Esophagitis
Eosinophilic Gastritis
Eosinophilic Enteritis
Eosinophilic Colitis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 21 Years
Official Title: Eosinophilic Gastrointestinal Disorders Patient Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • To define characteristics of an eosinophilic gastrointestinal disorder population in a rural southern state [ Time Frame: After 12 months of data collection ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: January 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
eosinophilic gastrointestinal disorders
Individuals with a diagnosis of EGID including: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with a diagnosis of an eosinophilic gastrointestinal disorder

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779154

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Robbie D Pesek, MD University of Arkansas for Medical Sciences / Arkansas Children's Hospital Research Institute
  More Information

No publications provided

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01779154     History of Changes
Other Study ID Numbers: 136132
Study First Received: January 28, 2013
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
eosinophilic esophagitis
eosinophilic gastritis
eosinophilic enteritis
eosinophilic colitis

Additional relevant MeSH terms:
Colitis
Enteritis
Esophagitis
Gastritis
Digestive System Diseases
Gastrointestinal Diseases
Eosinophilic Esophagitis
Eosinophilia
Gastroenteritis
 Colonic Diseases
Intestinal Diseases
Esophageal Diseases
Stomach Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013