Erosive EsophagitisNCT01865825
Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?
An observational study of Erosive Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- Esophageal Barium Xray
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with GERD that have been currently diagnosed with erosive esophagitis at endoscopy, at Mayo Clinic Rochester, Minnesota
Who may be able to join
- Age 18 or older
- Have either mild-to-moderate Los Angeles (LA) Classification System grade B, moderately severe LA grade C, or severe LA grade D erosive reflux esophagitis
- Or patients having a clinically indicated pH/impedance monitoring on proton pump inhibitor therapy for indications of gastroesophageal reflux disease.
Who cannot join
- Neoplasm of the esophagus or stomach
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
- Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis?
The investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis.
If this group of patients exists, the investigators would like to determine if they have the typical endoscopic features of EoE rather than those of GERD.
- Conditions
- Erosive Esophagitis
- Being tested
- Esophageal Barium Xray
- Keywords
- Erosive Esophagitis, Gastroesophageal reflux disease
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal Barium XrayRadiation
Also called GERD, Erosive Esophagitis
•Fast for 4 hours prior to the Esophagram (upper GI x-ray). You will drink a liquid that has barium or another contrast agent in it. The radiologist will use the X-ray machine to look at your upper GI tract while you drink the contrast liquid. The x-ray exam should take between 10-15 minutes.
We will have patients complete the Mayo Dysphasia Questionnaire-30 day.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal barium xray | We will recruit 20 patients with GERD without dysphagia for an esophageal barium xray for esophageal diameter measurements.
The 20 Gastroesophageal Reflux Disease (GERD) patients will complete the Mayo Dysphagia Questionnaire 30-day and the Eosinophilic Esophagitis Actitivy Index (EEsAI) questionnaires Receives: Radiation: Esophageal Barium Xray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal esophageal distensibility in patients with PPI responsive Eosinophilic Infiltrates to patients with Eosionophilic esophagitis and Gastroesophageal Reflux Disease.
We will evaluate endoscopic features of Gastroesophageal Reflux Disease(GERD) by reviewing endoscopic reports and images. The presence of esophageal narrowing, furrows, rings, fragility, and white spots will be noted form the endoscopic reports prior to the initiation of the Provation report system. We will review the endoscopic reports and the endoscopic photographs on those patients evaluated after the Provation report system was initiated. All images will be reviewed by one investigator unaware of the subjects clinical data and name
Measured: 1 year
Secondary outcomes (1)
The relationship of abnormal esophageal distensibility to other endoscopic findings of EoE (furrows, rings, fragility, stricture)
After reviewing endoscopic features of GERD by reviewing endoscopic reports and images. The presence of esophageal narrowing, furrows, rings, fragility, and white spots will be noted form the endoscopic reports prior to the initiation of the Provation report system. We will determine the relationship of abnormal esophagus distensibility to the endoscopic findings
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey A Alexander, Mayo Clinic
- Investigators
- Jeffrey Alexander, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865825
- Sponsor's protocol ID
- 12-009305
- Status last verified
- Mar 2017
- First submitted
- 23 May 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis?
- ClinicalTrials.gov ID
- NCT01865825
- Acronym / sponsor ID
- 12-009305
- Conditions
- Erosive Esophagitis
- Keywords
- Erosive Esophagitis, Gastroesophageal reflux disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 31 May 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 investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis.
If this group of patients exists, the investigators would like to determine if they have the typical endoscopic features of EoE rather than those of GERD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophageal barium xray | – | Radiation: Esophageal Barium XrayWe will recruit 20 patients with GERD without dysphagia for an esophageal barium xray for esophageal diameter measurements. The 20 Gastroesophageal Reflux Disease (GERD) patients will complete the Mayo Dysphagia Questionnaire 30-day and the Eosinophilic Esophagitis Actitivy Index (EEsAI) questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with GERD that have been currently diagnosed with erosive esophagitis at endoscopy, at Mayo Clinic Rochester, Minnesota
Key inclusion criteria (3 listed)
- Age 18 or older
- Have either mild-to-moderate Los Angeles (LA) Classification System grade B, moderately severe LA grade C, or severe LA grade D erosive reflux esophagitis
- Or patients having a clinically indicated pH/impedance monitoring on proton pump inhibitor therapy for indications of gastroesophageal reflux disease.
Key exclusion criteria (3 listed)
- Neoplasm of the esophagus or stomach
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
- Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal Barium XrayAlso: GERD, Erosive Esophagitis•Fast for 4 hours prior to the Esophagram (upper GI x-ray). You will drink a liquid that has barium or another contrast agent in it. The radiologist will use the X-ray machine to look at your upper GI tract while you drink the contrast liquid. The x-ray exam should take between 10-15 minutes. We will have patients complete the Mayo Dysphasia Questionnaire-30 day. | Radiation | Esophageal barium xray |
Primary outcome
Abnormal esophageal distensibility in patients with PPI responsive Eosinophilic Infiltrates to patients with Eosionophilic esophagitis and Gastroesophageal Reflux Disease.
Time frame: 1 year
We will evaluate endoscopic features of Gastroesophageal Reflux Disease(GERD) by reviewing endoscopic reports and images. The presence of esophageal narrowing, furrows, rings, fragility, and white spots will be noted form the endoscopic reports prior to the initiation of the Provation report system. We will review the endoscopic reports and the endoscopic photographs on those patients evaluated after the Provation report system was initiated. All images will be reviewed by one investigator unaware of the subjects clinical data and name
1 secondary outcome
The relationship of abnormal esophageal distensibility to other endoscopic findings of EoE (furrows, rings, fragility, stricture)
Time frame: 1 year
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 22 Mar 2017.
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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.
Jeffrey Alexander, MD principal investigator
Mayo Clinic
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 Erosive Esophagitis, run by Mayo Clinic 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 3 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 22 Mar 2017. 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 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?
Abnormal esophageal distensibility in patients with PPI responsive Eosinophilic Infiltrates to patients with Eosionophilic esophagitis and Gastroesophageal Reflux Disease. (time frame: 1 year). 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 22 Mar 2017.