Eosinophilic EsophagitisNCT01779154
Eosinophilic Gastrointestinal Disorders Patient Registry
An observational study of Eosinophilic Esophagitis and Eosinophilic Gastritis, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Enteritis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2017
- How long will I take part?
- 21 Years
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals with a diagnosis of an eosinophilic gastrointestinal disorder
Who may be able to join
- 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
Who cannot join
- hypereosinophilic syndrome
- non-eosinophilic gastrointestinal or allergic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
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.
- Conditions
- Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Enteritis, Eosinophilic Colitis
- Keywords
- eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis
- Medical subject headings
- Eosinophilic Esophagitis, Eosinophilic enteropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| eosinophilic gastrointestinal disorders | Individuals with a diagnosis of EGID including: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define characteristics of an eosinophilic gastrointestinal disorder population in a rural southern state
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.
Measured: After 12 months of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2016
- Study completionMay 2017 (estimated)
Why it stopped: funding not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 21 Years
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robbie D Pesek, MD, Principal investigator, University of Arkansas for Medical Sciences / Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779154
- Sponsor's protocol ID
- 136132
- Status last verified
- Jun 2016
- First submitted
- 28 Jan 2013
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pesek RD, Rettiganti M, O'Brien E, Beckwith S, Daniel C, Luo C, Scurlock AM, Chandler P, Levy RA, Perry TT, Kennedy JL, Chervinskiy S, Vonlanthen M, Casteel H, Fiedorek SC, Gibbons T, Jones SM. Effects of allergen sensitization on response to therapy in children with eosinophilic esophagitis. Ann Allergy Asthma Immunol. 2017 Aug;119(2):177-183. doi: 10.1016/j.anai.2017.06.006. Epub 2017 Jul 1.
PubMed 28676207
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eosinophilic Gastrointestinal Disorders Patient Registry
- ClinicalTrials.gov ID
- NCT01779154
- Acronym / sponsor ID
- 136132
- Conditions
- Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Enteritis, Eosinophilic Colitis
- Keywords
- eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: funding not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 30 Jan 2013 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eosinophilic gastrointestinal disorders | – | –Individuals with a diagnosis of EGID including: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals with a diagnosis of an eosinophilic gastrointestinal disorder
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- hypereosinophilic syndrome
- non-eosinophilic gastrointestinal or allergic disorder
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
To define characteristics of an eosinophilic gastrointestinal disorder population in a rural southern state
Time frame: After 12 months of data collection
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Derived from this study: PubMed 28676207Pesek RD, Rettiganti M, O'Brien E, Beckwith S, Daniel C, Luo C, Scurlock AM, Chandler P, Levy RA, Perry TT, Kennedy JL, Chervinskiy S, Vonlanthen M, Casteel H, Fiedorek SC, Gibbons T, Jones SM. Effects of allergen sensitization on response to therapy in children with eosinophilic esophagitis. Ann Allergy Asthma Immunol. 2017 Aug;119(2):177-183. doi: 10.1016/j.anai.2017.06.006. Epub 2017 Jul 1.
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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.
Robbie D Pesek, MD principal investigator
University of Arkansas for Medical Sciences / Arkansas Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis and Eosinophilic Gastritis, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
To define characteristics of an eosinophilic gastrointestinal disorder population in a rural southern state (time frame: After 12 months of data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779154, which also lists 1 linked publication.
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 20 Jun 2016.