- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02190513
Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease
July 14, 2014 updated by: Hernando Lyons, MD, St. John Health System, Michigan
Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease and Prevalence of Celiac Disease in Children With Eosinophilic Esophagitis in a Tertiary Community Hospital
Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the gastrointestinal tract with specific clinico-pathological characteristics.
In recent years, in the literature, several children who underwent upper gastrointestinal endoscopy for suspected CD, which was confirmed histologically, were also found to have coexistent EE.
There are reports of coexistent CD and EE.
We would like to see the prevalence of EE in children with CD and the prevalence of CD in children with EE in our population, and to do so would like to review medical records.
Our objectives are to determine if children with celiac disease have a high prevalence of eosinophilic esophagitis.and
to determine if children with eosinophilic esophagitis have increased risk of developing celiac disease.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
56
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children seen in the Pediatric Gastroenterology clinic at St. John Hospital & Medical Center and diagnosed with celiac disease or eosinophilic esophagitis or both based on the endoscopic and histopathological findings.
Description
Inclusion Criteria:
- Seen in the Pediatric Gastroenterology clinic at St. John Hospital & Medical Center during study time frame
- Age 2-21 years old
- Diagnosed with CD or EE or both based on the endoscopic and histopathological findings .
Exclusion Criteria:
- Gastroesophageal reflux diagnosed by PH probe.
- History of chemical ingestion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Review of histopathology reports of esophageal biopsies to record the number of eosinophils per high power field.
Time Frame: Retrospective chart review study, no contact made with patients, so no patient time is required, expected average of 2 years
|
Retrospective chart review study, no contact made with patients, so no patient time is required, expected average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
July 10, 2014
First Submitted That Met QC Criteria
July 14, 2014
First Posted (Estimate)
July 15, 2014
Study Record Updates
Last Update Posted (Estimate)
July 15, 2014
Last Update Submitted That Met QC Criteria
July 14, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Hematologic Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Hypersensitivity
- Esophageal Diseases
- Leukocyte Disorders
- Malabsorption Syndromes
- Eosinophilia
- Celiac Disease
- Eosinophilic Esophagitis
- Esophagitis
Other Study ID Numbers
- SJ 0211-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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