NCT02190513

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

July 10, 2014

Last Update Submit

July 14, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Review of histopathology reports of esophageal biopsies to record the number of eosinophils per high power field.

    Retrospective chart review study, no contact made with patients, so no patient time is required, expected average of 2 years

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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 .

You may not qualify if:

  • Gastroesophageal reflux diagnosed by PH probe.
  • History of chemical ingestion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Celiac DiseaseEosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesEsophagitisEsophageal DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
tSection Chief of Pediatric Gastroenterology at St. John Hospital and Medical Center

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 15, 2014

Study Start

February 1, 2011

Primary Completion

June 1, 2013

Last Updated

July 15, 2014

Record last verified: 2014-07