DysphagiaNCT01028235
Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia
An observational study of Dysphagia, run by San Antonio Uniformed Services Health Education Consortium at 2 sites in United States.
Trial summary
The purpose of this study is to identify the prevalence of pathologic eosinophilic esophagitis (EoE) in the cohort of adult patients who present for specialty care in the gastroenterology clinics with complaint of difficulty swallowing (dysphagia). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to Jan 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients over age 18, presenting to the Gastroenterology Clinic with the complaint of dysphagia
Who may be able to join
- age > 18
- complaint of dysphagia
Who cannot join
- pregnancy
- age <18
- on inhaled steroids within the last 30 days
- on systemic steroids in the last 30 days
- known diagnosis of Eosinophilic Esophagitis
- obvious obstructive etiology found at endoscopy
- increased risk of bleeding (on blood thinners or anti-platelet agents other than aspirin)
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Wilford Hall Medical Center
San Antonio, Texas, 78236
Jonathan M Ricker, DO, 210-292-6408, jonathan.ricker@lackland.af.mil
Kevin J Franklin, MD, 210-292-6408, kevin.franklin1@lackland.af.mil
- Recruiting
Brooke Army Medical Center
San Antonio, Texas, 78245
Scott McNear, DO, 210-916-5244, scott.mcnear@amedd.army.mil
Hays Arnold, MD, 210-916-5244, hays.arnold@amedd.army.mil
About this study
The purpose of this study is to identify the prevalence of pathologic eosinophilic esophagitis (EoE) in the cohort of adult patients who present for specialty care in the gastroenterology clinics with complaint of difficulty swallowing (dysphagia). From this, the investigators will make recommendations regarding routine screening for the diagnosis in this cohort. The prevalence of EoE in patients presenting for specialty care in the gastroenterology clinics with the complaint of dysphagia is great enough that the diagnosis should be routinely screened against in this cohort.
- Conditions
- Dysphagia
- Keywords
- Eosinophilic Esophagitis
- Medical subject headings
- Deglutition Disorders, Eosinophilic Esophagitis
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 |
|---|---|---|
| Obstructive Dysphagia | Patients who complained of dysphagia, which had an obstructive etiology for their symptoms at the time of endoscopy (ring, mass, stricture, etc) | |
| Non-obstructive Dysphagia | Patients whose endoscopy was normal and without any obvious etiology for their symptoms noted. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJan 2006
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Antonio Uniformed Services Health Education Consortium
- Sponsor type
- US federal agency
- Investigators
- Jonathan M Ricker, DO, Principal investigator, San Antonio Uniformed Services Health Education Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028235
- Sponsor's protocol ID
- FWH20060112H
- Status last verified
- Nov 2009
- First submitted
- 8 Dec 2009
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia
- ClinicalTrials.gov ID
- NCT01028235
- Acronym / sponsor ID
- FWH20060112H
- Conditions
- Dysphagia
- Keywords
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- San Antonio Uniformed Services Health Education ConsortiumUS federal agency
- Study start
- Jan 2006
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 9 Dec 2009 (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 purpose of this study is to identify the prevalence of pathologic eosinophilic esophagitis (EoE) in the cohort of adult patients who present for specialty care in the gastroenterology clinics with complaint of difficulty swallowing (dysphagia). From this, the investigators will make recommendations regarding routine screening for the diagnosis in this cohort. The prevalence of EoE in patients presenting for specialty care in the gastroenterology clinics with the complaint of dysphagia is great enough that the diagnosis should be routinely screened against in this cohort.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Dysphagia | – | –Patients who complained of dysphagia, which had an obstructive etiology for their symptoms at the time of endoscopy (ring, mass, stricture, etc) |
| Non-obstructive Dysphagia | – | –Patients whose endoscopy was normal and without any obvious etiology for their symptoms noted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients over age 18, presenting to the Gastroenterology Clinic with the complaint of dysphagia
Key inclusion criteria (2 listed)
- age > 18
- complaint of dysphagia
Key exclusion criteria (7 listed)
- pregnancy
- age <18
- on inhaled steroids within the last 30 days
- on systemic steroids in the last 30 days
- known diagnosis of Eosinophilic Esophagitis
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
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.
Jonathan M Ricker, DO principal investigator
San Antonio Uniformed Services Health Education Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by San Antonio Uniformed Services Health Education Consortium at 2 sites 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan M Ricker, DO (210-292-6408, jonathan.ricker@lackland.af.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 9 Dec 2009.