Celiac DiseaseNCT02190513
Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease
An observational study of Celiac Disease and Eosinophilic Esophagitis, run by St. John Health System, Michigan.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Celiac Disease, Eosinophilic Esophagitis
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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 .
Who cannot join
- Gastroesophageal reflux diagnosed by PH probe.
- History of chemical ingestion
About this study
Official title: 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.
- Conditions
- Celiac Disease, Eosinophilic Esophagitis
- Medical subject headings
- Celiac Disease, Eosinophilic Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Review of histopathology reports of esophageal biopsies to record the number of eosinophils per high power field.
Measured: Retrospective chart review study, no contact made with patients, so no patient time is required, expected average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startFeb 2011
- Primary completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. John Health System, Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hernando Lyons, MD, St. John Health System, Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190513
- Sponsor's protocol ID
- SJ 0211-07
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease and Prevalence of Celiac Disease in Children With Eosinophilic Esophagitis in a Tertiary Community Hospital
- ClinicalTrials.gov ID
- NCT02190513
- Acronym / sponsor ID
- SJ 0211-07
- Conditions
- Celiac Disease, Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- St. John Health System, MichiganUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2013 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (2 listed)
- Gastroesophageal reflux diagnosed by PH probe.
- History of chemical ingestion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease and Eosinophilic Esophagitis, run by St. John Health System, Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.