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Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders
This study is currently recruiting participants.
Verified by Children's Hospital Medical Center, Cincinnati, August 2009
First Received: December 15, 2005   Last Updated: August 26, 2009   History of Changes
Sponsors and Collaborators: Children's Hospital Medical Center, Cincinnati
Rothenberg, Marc E., M.D., Ph.D.
Information provided by: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00267501
  Purpose

The purpose of this study is to elucidate the mechanisms underlying eosinophil growth, survival, migration, and function and to investigate and further characterize the pathophysiology of, clinical manifestations of, and spectrum of disease severity of eosinophilic inflammation in humans.


Condition
Eosinophilic Gastrointestinal Disease Eosinophilic Inflammatory Disease
Food Allergy

Study Type: Observational
Study Design: Prospective
Official Title: Eosinophils and Inflammation, an Expanded Study

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Estimated Enrollment: 500
Study Start Date: May 2005
  Eligibility

Ages Eligible for Study:   1 Year to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with eosinophilic disorders and patients without eosinophilic disorders to serve as normal controls

Criteria

Inclusion Criteria:

  • Signed informed consent obtained from the patient or parent/guardian. Assent will be obtained from all minors 11 years of age and older.
  • Age 1-65 years.
  • Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy
  • Other inclusion criteria may include: undergoing endoscopy based on evaluation by a pediatric CCHMC gastroenterologist

Exclusion Criteria:

  • Recent viral infection (in preceding 1-2 weeks) such as upper respiratory tract infection, tonsillitis, or gastroenteritis. Viral infections in general may suppress or alter some cellular responses, especially lymphocyte responses in vivo.
  • Oral or esophageal infections including candidiasis in the preceding 2 weeks
  • Known diagnosis of another systemic or gastrointestinal inflammatory condition including, but not limited to, ulcerative colitis, Crohn's disease, indeterminate colitis, celiac disease, cystic fibrosis, or immunodeficiency.
  • Concurrent use of systemic steroids, antihistamines, or other immunomodulatory drugs that may alter cellular responses.
  • Concurrent use of anticoagulant medications which may alter cellular responses.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267501

Contacts
Contact: Tommie M Grotjan, M.S. 513-803-1655 tommie.grotjan@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Principal Investigator: Marc E. Rothenberg, M.D., Ph.D.            
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Rothenberg, Marc E., M.D., Ph.D.
Investigators
Principal Investigator: Marc E. Rothenberg, M.D., Ph.D. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Cincinnati Children's Hospital Medical Center ( Marc Rothenberg, M.D., Ph.D. )
Study ID Numbers: 04-12-8, R01 DK075401
Study First Received: December 15, 2005
Last Updated: August 26, 2009
ClinicalTrials.gov Identifier: NCT00267501     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Eosinophilic Disorders

Study placed in the following topic categories:
Food Hypersensitivity
Hypersensitivity
Digestive System Diseases
Hematologic Diseases
Gastrointestinal Diseases
Hypersensitivity, Immediate
Leukocyte Disorders
Eosinophilia
Inflammation

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Digestive System Diseases
Immune System Diseases
Hematologic Diseases
Gastrointestinal Diseases
Hypersensitivity, Immediate
Leukocyte Disorders
Eosinophilia

ClinicalTrials.gov processed this record on September 02, 2009