Eosinophilic EsophagitisEoENCT03290482
Natural History of Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its progression and effects of treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Barium Esophagram, EsophaCap and Physical Examination and Questionnaires
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 25 Mar 2020
- 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: Eosinophilic Esophagitis patients that we have been following for 10 years and participated in the previous study.
Who may be able to join
- Adults 18 years of age and older
- Previous participation in the natural history followup study
Who cannot join
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 Years
Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its progression and effects of treatments.
Read the detailed description
Investigators will identify patients from their database who have been diagnosed with Eosinophilic Esophagitis (EE) from the study period 2000 to 2008, based on clinical features and biopsy findings. Participants will be offered a follow up evaluation that includes: evaluation by the Principal Investigator, completion of questionnaires, Esophagram and Esophageal sponge (EsophaCap) cytology.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Barium Esophagram, EsophaCap, Physical Examination and Questionnaires
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barium EsophagramDiagnostic test
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.
EsophaCapDevice
Also called Sponge
Subjects will swallow the EsophaCap, which has a string attached, 10 minutes later it has devolved in the stomach. The PI will pull the string to remove the EsophaCap. We will send the sponge for cytology assessing the histologic results of eosinophils per high power field (phf)
Physical Examination and QuestionnairesDiagnostic test
Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) at time of physical exam visit with PI.
| Study group | Role | What they receive |
|---|---|---|
| EE Study Patients 2000-2008 | All patients with the diagnosis of EE from the study period 2000 to 2008. Sixty patients participated in the 10 year follow up phone interview and questionnaire. These are the subjects we will contact to see if they are interested in participating in this study.
If interested in participating, subjects will complete:
1. Evaluation by the PI physical examination
2. Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) questionnaires
3. Barium Esophagram with maximal and minimal esophageal diameter measurement
4. EsophaCap cytology Receives: Diagnostic Test: Barium Esophagram; Device: EsophaCap; Diagnostic Test: Physical Examination and Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural history of treated Eosinophilic Esophagitis (EE)
The number of recurrent symptoms using the modified Mayo Dysphagia Questionnaire (MDQ). The MDQ is a 32 - item instrument in which symptoms are divided into three symptom domains.
Measured: approximately 1 year
Natural history of untreated Eosinophilic Esophagitis (EE)
The number of recurrent symptoms using the modified Mayo Dysphagia Questionnaire (MDQ). The MDQ is a 32 - item instrument in which symptoms are divided into three symptom domains.
Measured: approximately 1 year
Natural history of treated Eosinophilic Esophagitis (EoE)
The number of recurrent symptoms using the Eosinophilic Esophagitis Activity Index (EEsAI). The EEsAI provides a visual analogue of foods for subjects to examine and rate for difficulty in swallowing ranging from severe difficulties to No difficulties.
Measured: approximately 1 year
Natural history of untreated Eosinophilic Esophagitis (EoE)
The number of recurrent symptoms using the Eosinophilic Esophagitis Activity Index (EEsAI). The EEsAI provides a visual analogue of foods for subjects to examine and rate for difficulty in swallowing ranging from severe difficulties to No difficulties.
Measured: approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start19 Jun 2017
- Primary completion1 Nov 2019
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 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 A Alexander, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290482
- Sponsor's protocol ID
- 17-002067
- Acronym
- EoE
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2017
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cherian S, Smith NM, Forbes DA. Rapidly increasing prevalence of eosinophilic oesophagitis in Western Australia. Arch Dis Child. 2006 Dec;91(12):1000-4. doi: 10.1136/adc.2006.100974. Epub 2006 Jul 28.
PubMed 16877474Landres RT, Kuster GG, Strum WB. Eosinophilic esophagitis in a patient with vigorous achalasia. Gastroenterology. 1978 Jun;74(6):1298-1301.
PubMed 648822Fox VL, Nurko S, Furuta GT. Eosinophilic esophagitis: it's not just kid's stuff. Gastrointest Endosc. 2002 Aug;56(2):260-70. doi: 10.1016/s0016-5107(02)70188-0. No abstract available.
PubMed 12145607Straumann A, Spichtin HP, Grize L, Bucher KA, Beglinger C, Simon HU. Natural history of primary eosinophilic esophagitis: a follow-up of 30 adult patients for up to 11.5 years. Gastroenterology. 2003 Dec;125(6):1660-9. doi: 10.1053/j.gastro.2003.09.024.
PubMed 14724818Arora AS, Yamazaki K. Eosinophilic esophagitis: asthma of the esophagus? Clin Gastroenterol Hepatol. 2004 Jul;2(7):523-30. doi: 10.1016/s1542-3565(04)00236-8.
PubMed 15224275Noel RJ, Putnam PE, Rothenberg ME. Eosinophilic esophagitis. N Engl J Med. 2004 Aug 26;351(9):940-1. doi: 10.1056/NEJM200408263510924. No abstract available.
PubMed 15329438Straumann A, Simon HU. Eosinophilic esophagitis: escalating epidemiology? J Allergy Clin Immunol. 2005 Feb;115(2):418-9. doi: 10.1016/j.jaci.2004.11.006. No abstract available.
PubMed 15696105Morrow JB, Vargo JJ, Goldblum JR, Richter JE. The ringed esophagus: histological features of GERD. Am J Gastroenterol. 2001 Apr;96(4):984-9. doi: 10.1111/j.1572-0241.2001.03682.x.
PubMed 11316216
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 Years
- ClinicalTrials.gov ID
- NCT03290482
- Acronym / sponsor ID
- EoE / 17-002067
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 25 Sep 2017 (actual)
- 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.
Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its progression and effects of treatments.
Detailed description
Investigators will identify patients from their database who have been diagnosed with Eosinophilic Esophagitis (EE) from the study period 2000 to 2008, based on clinical features and biopsy findings. Participants will be offered a follow up evaluation that includes: evaluation by the Principal Investigator, completion of questionnaires, Esophagram and Esophageal sponge (EsophaCap) cytology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EE Study Patients 2000-2008 | – | Diagnostic Test: Barium Esophagram, Device: EsophaCap, Diagnostic Test: Physical Examination and QuestionnairesAll patients with the diagnosis of EE from the study period 2000 to 2008. Sixty patients participated in the 10 year follow up phone interview and questionnaire. These are the subjects we will contact to see if they are interested in participating in this study. If interested in participating, subjects will complete: 1. Evaluation by the PI physical examination 2. Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) questionnaires 3. Barium Esophagram with maximal and minimal esophageal diameter measurement 4. EsophaCap cytology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eosinophilic Esophagitis patients that we have been following for 10 years and participated in the previous study.
Key inclusion criteria (2 listed)
- Adults 18 years of age and older
- Previous participation in the natural history followup study
Key exclusion criteria (2 listed)
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
- Pregnant women
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 |
|---|---|---|
| Barium EsophagramFast 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. | Diagnostic test | EE Study Patients 2000-2008 |
| EsophaCapAlso: SpongeSubjects will swallow the EsophaCap, which has a string attached, 10 minutes later it has devolved in the stomach. The PI will pull the string to remove the EsophaCap. We will send the sponge for cytology assessing the histologic results of eosinophils per high power field (phf) | Device | EE Study Patients 2000-2008 |
| Physical Examination and QuestionnairesComplete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) at time of physical exam visit with PI. | Diagnostic test | EE Study Patients 2000-2008 |
Primary outcome
Natural history of treated Eosinophilic Esophagitis (EE)
Time frame: approximately 1 year
The number of recurrent symptoms using the modified Mayo Dysphagia Questionnaire (MDQ). The MDQ is a 32 - item instrument in which symptoms are divided into three symptom domains.
Natural history of untreated Eosinophilic Esophagitis (EE)
Time frame: approximately 1 year
The number of recurrent symptoms using the modified Mayo Dysphagia Questionnaire (MDQ). The MDQ is a 32 - item instrument in which symptoms are divided into three symptom domains.
Natural history of treated Eosinophilic Esophagitis (EoE)
Time frame: approximately 1 year
The number of recurrent symptoms using the Eosinophilic Esophagitis Activity Index (EEsAI). The EEsAI provides a visual analogue of foods for subjects to examine and rate for difficulty in swallowing ranging from severe difficulties to No difficulties.
Natural history of untreated Eosinophilic Esophagitis (EoE)
Time frame: approximately 1 year
The number of recurrent symptoms using the Eosinophilic Esophagitis Activity Index (EEsAI). The EEsAI provides a visual analogue of foods for subjects to examine and rate for difficulty in swallowing ranging from severe difficulties to No difficulties.
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 12 Aug 2021.
- Background: PubMed 16877474Cherian S, Smith NM, Forbes DA. Rapidly increasing prevalence of eosinophilic oesophagitis in Western Australia. Arch Dis Child. 2006 Dec;91(12):1000-4. doi: 10.1136/adc.2006.100974. Epub 2006 Jul 28.
- Background: PubMed 648822Landres RT, Kuster GG, Strum WB. Eosinophilic esophagitis in a patient with vigorous achalasia. Gastroenterology. 1978 Jun;74(6):1298-1301.
- Background: PubMed 12145607Fox VL, Nurko S, Furuta GT. Eosinophilic esophagitis: it's not just kid's stuff. Gastrointest Endosc. 2002 Aug;56(2):260-70. doi: 10.1016/s0016-5107(02)70188-0. No abstract available.
- Background: PubMed 14724818Straumann A, Spichtin HP, Grize L, Bucher KA, Beglinger C, Simon HU. Natural history of primary eosinophilic esophagitis: a follow-up of 30 adult patients for up to 11.5 years. Gastroenterology. 2003 Dec;125(6):1660-9. doi: 10.1053/j.gastro.2003.09.024.
- Background: PubMed 15224275Arora AS, Yamazaki K. Eosinophilic esophagitis: asthma of the esophagus? Clin Gastroenterol Hepatol. 2004 Jul;2(7):523-30. doi: 10.1016/s1542-3565(04)00236-8.
- Background: PubMed 15329438Noel RJ, Putnam PE, Rothenberg ME. Eosinophilic esophagitis. N Engl J Med. 2004 Aug 26;351(9):940-1. doi: 10.1056/NEJM200408263510924. No abstract available.
- Background: PubMed 15696105Straumann A, Simon HU. Eosinophilic esophagitis: escalating epidemiology? J Allergy Clin Immunol. 2005 Feb;115(2):418-9. doi: 10.1016/j.jaci.2004.11.006. No abstract available.
- Background: PubMed 11316216Morrow JB, Vargo JJ, Goldblum JR, Richter JE. The ringed esophagus: histological features of GERD. Am J Gastroenterol. 2001 Apr;96(4):984-9. doi: 10.1111/j.1572-0241.2001.03682.x.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 A 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 Eosinophilic 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 2 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 12 Aug 2021. 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?
Natural history of treated Eosinophilic Esophagitis (EE) (time frame: approximately 1 year). The study lists 4 primary outcomes in all. 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 NCT03290482, which also lists 8 linked publications.
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 12 Aug 2021.