Eosinophilic Esophagitis (EoE)NCT03581838
Eating With Eosinophilic Esophagitis (EoE)
An observational study of Eosinophilic Esophagitis (EoE), run by Mayo Clinic at 1 site in United States.
Trial summary
Is there a difference in the eating process for patients with active Eosinophilic Esophagitis (EoE) and those with inactive disease? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- What is being tested?
- Observed eating session
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2018to 23 Jul 2019
- 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: Individuals with EoE that are being seen at Mayo Clinic Esophageal Clinic will be approached. Controls will be individuals who do not have an EoE diagnosis.
Who may be able to join
- 18 years of age and older
- Patients suspected to have Eosinophilic Esophagitis
- Patients being treated for EoE with PPI or a steriod
- EoE patients that are in remission by having less than 22 on the EEsAI questionnaire
- Controls, patients that do not have EoE or other swallowing issues
Who cannot join
- Clinical evidence of infectious process potentially contributing to dysphagia (candidiasis, CMV,herpes)
- Other cause of dysphagia identified at endoscopy (reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
- EoE patients that do not eat sandwiches or feel they could not eat a sandwich.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Eating Behavior in Patients With Eosinophilic Esophagitis.
Is there a difference in the eating process for patients with active Eosinophilic Esophagitis (EoE) and those with inactive disease?
Read the detailed description
Eosinophilic esophagitis (EoE) patients develop adapted eating behaviors to prevent symptoms. These patients tend to cut their food small, chew extensively, take copious liquids with meals, and avoid foods that cause symptoms. No studies to date have directly evaluated these eating behaviors in patients with EoE with observation. Furthermore, none of the investigators' current metrics for patient symptom assessment visually evaluate the eating process nor are they compared before and after treatment. As a result, it is unclear if a patient's subjective perception of their eating difficulties and improvement matches with objective measures.
- Conditions
- Eosinophilic Esophagitis (EoE)
- Being tested
- Observed eating session
- Keywords
- EoE, Dysphagia
- Medical subject headings
- Eosinophilic Esophagitis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observed eating sessionBehavioural
Eating a Jimmy Johns turkey or vegetarian sandwich
| Study group | Role | What they receive |
|---|---|---|
| Acitve EoE | Observed eating session of Jimmy John's turkey or vegetarian sandwich with water among individuals who have EoE who have not been treated or have not achieved remission from treatment. Receives: Behavioral: Observed eating session | |
| Remission EoE | Observed eating session of Jimmy John's turkey or vegetarian sandwich with water among individuals who have EoE who are have achieved remission from treatment. Receives: Behavioral: Observed eating session | |
| Controls | Observed eating session of Jimmy John's turkey or vegetarian sandwich with water among individuals without EoE. Receives: Behavioral: Observed eating session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed eating session
number of bites of patient's with EoE and controls eating a Jimmy John's sandwich
Measured: 15-90 minutes
Secondary outcomes (4)
Food slowness during eating session
number of bites that felt stuck among patients with EoE and controls when eating a Jimmy John's sandwich
Measured: 15-90 minutes
Water during eating session
amount of water drank of patients with EoE and controls eating a Jimmy John's sandiwch
Measured: 15-90 minutes
Eosinophilic Esophagitis activity Index (EEsAI) questionnaire
The EEsAI Pro uses the VDQ is visual dysphagia question AMS is avoidance, modification, slow eating question . These two along with questions on frequency of, duration of, pain associated with dysphagia make up the PRO (patient reported outcomes). The PRO is a number (0-100) calculated from the answer to the questions. A PRO < 20 defines asymptomatic EoE.
Measured: 10-15 minutes
Eosinophilic Esophagitis Quality of Life questionnaire
Higher score denote better quality of life. 0-4 as follows 4=not at all, 3=Slightly 2=moderately, 1=Quite a bit, 0= Extremely
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start24 May 2018
- Primary completion23 Jul 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Esophagitis (EoE)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 31 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, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581838
- Sponsor's protocol ID
- 18-002628
- Status last verified
- Oct 2019
- First submitted
- 11 Jun 2018
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Behavior in Patients With Eosinophilic Esophagitis.
- ClinicalTrials.gov ID
- NCT03581838
- Acronym / sponsor ID
- 18-002628
- Conditions
- Eosinophilic Esophagitis (EoE)
- Keywords
- EoE, Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 10 Jul 2018 (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.
Is there a difference in the eating process for patients with active Eosinophilic Esophagitis (EoE) and those with inactive disease?
Detailed description
Eosinophilic esophagitis (EoE) patients develop adapted eating behaviors to prevent symptoms. These patients tend to cut their food small, chew extensively, take copious liquids with meals, and avoid foods that cause symptoms. No studies to date have directly evaluated these eating behaviors in patients with EoE with observation. Furthermore, none of the investigators' current metrics for patient symptom assessment visually evaluate the eating process nor are they compared before and after treatment. As a result, it is unclear if a patient's subjective perception of their eating difficulties and improvement matches with objective measures.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acitve EoE | – | Behavioral: Observed eating sessionObserved eating session of Jimmy John's turkey or vegetarian sandwich with water among individuals who have EoE who have not been treated or have not achieved remission from treatment. |
| Remission EoE | – | Behavioral: Observed eating sessionObserved eating session of Jimmy John's turkey or vegetarian sandwich with water among individuals who have EoE who are have achieved remission from treatment. |
| Controls | – | Behavioral: Observed eating sessionObserved eating session of Jimmy John's turkey or vegetarian sandwich with water among individuals without EoE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with EoE that are being seen at Mayo Clinic Esophageal Clinic will be approached. Controls will be individuals who do not have an EoE diagnosis.
Key inclusion criteria (5 listed)
- 18 years of age and older
- Patients suspected to have Eosinophilic Esophagitis
- Patients being treated for EoE with PPI or a steriod
- EoE patients that are in remission by having less than 22 on the EEsAI questionnaire
- Controls, patients that do not have EoE or other swallowing issues
Key exclusion criteria (3 listed)
- Clinical evidence of infectious process potentially contributing to dysphagia (candidiasis, CMV,herpes)
- Other cause of dysphagia identified at endoscopy (reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
- EoE patients that do not eat sandwiches or feel they could not eat a sandwich.
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 |
|---|---|---|
| Observed eating sessionEating a Jimmy Johns turkey or vegetarian sandwich | Behavioural | Acitve EoE, Controls, Remission EoE |
Primary outcome
Observed eating session
Time frame: 15-90 minutes
number of bites of patient's with EoE and controls eating a Jimmy John's sandwich
4 secondary outcomes
Food slowness during eating session
Time frame: 15-90 minutes
Water during eating session
Time frame: 15-90 minutes
Eosinophilic Esophagitis activity Index (EEsAI) questionnaire
Time frame: 10-15 minutes
Eosinophilic Esophagitis Quality of Life questionnaire
Time frame: 10-15 minutes
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 9 Oct 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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 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 (EoE), 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 5 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 9 Oct 2019. 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?
Observed eating session (time frame: 15-90 minutes). 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 9 Oct 2019.