Suspected Eosinophilic EsophagitisEOENCT00880906
Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis
A study testing Esophageal dilation and Steroid and Proton Pump Inhibitor Therapy in people with Suspected Eosinophilic Esophagitis, run by Vanderbilt University at 1 site in United States.
Trial summary
This study is for patients who have had a food impaction and/or difficulty swallowing, who are scheduled to have endoscopy, biopsy and possibly dilatation (stretching) of the esophagus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Suspected Eosinophilic Esophagitis
- What is being tested?
- Esophageal dilation and Steroid and Proton Pump Inhibitor Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female volunteers ≥18 years old.
- Patients with known or suspected Eosinophilic Esophagitis.
- Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia.
Who cannot join
- Use of oral corticosteroids.
- Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety.
- Contraindication to esophageal dilation based on investigator's judgment.
- Esophageal motility abnormalities not thought to be related to Eosinophilic Esophagitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Unversity Medical Center Department of Gastroenterology
Nashville, Tennessee, 37212
About this study
Official title: Prospective, Single-Blinded, Randomized Controlled Trial With Sham Comparing Standard Therapy With or Without Esophageal Dilatation in Patients With Eosinophilic Esophagitis
This study is for patients who have had a food impaction and/or difficulty swallowing, who are scheduled to have endoscopy, biopsy and possibly dilatation (stretching) of the esophagus.
Standard treatment for people who have food impaction and difficulty swallowing is endoscopy to view the esophagus, tissue biopsies of the lining of the esophagus for diagnosis, and drug therapy including steroids and drugs used to treat reflux disease. Early dilatation or stretching of the esophagus may be done at this time but not always. Some doctors prefer to wait and see if the drugs are affective.
Read more
It is not known if dilating the esophagus early in treatment adds benefit. Therefore, we are doing this study to compare the two methods of treatment. We will compare two groups: one group will have dilatation performed during the first endoscopy and one group will not have dilatation performed during endoscopy. We will see if dilatation helps prevent food impaction and improves swallowing.
Another purpose of this study is to learn more about the causes of swallowing problems, thus extra biopsies will be taken of the esophagus and store them for future research.
Read the detailed description
Eosinophilic esophagitis (EE) is an inflammatory condition of the esophagus found in the pediatric and adult population. It is characterized by an intense eosinophilic infiltration of the surface lining of the esophagus. EE is becoming an increasingly recognized diagnosis in individuals presenting with food bolus impaction and dysphagia. A history of chronic solid food dysphagia, food impaction and young age have all been noted characteristics in those patients subsequently diagnosed with EE. Eosinophilic esophagitis can be suspected by clinical presentation but histologic confirmation is necessary for a definitive diagnosis. The finding of large numbers of eosinophils (>15 per high powered field) on biopsy specimens are needed to confirm EE. Endoscopic features such as mucosal rings, linear furrows, proximal strictures and white esophageal papules have all been described in patients with EE.
The underlying pathophysiology of EE is poorly understood but is thought to be associated with a TH2-type allergic inflammatory response. Other studies have also suggested that immune dysregulation may play a role in the underlying pathophysiology of this disorder.
The optimal treatment of EE has not been determined. There have been studies noting that swallowed fluticasone propionate (FP), an inhaled corticosteroid, has shown benefit in adult and pediatric patients with EE. Esophageal dilation has been used in patients with EE with persistent dysphagia and food impaction. No study has evaluated the improvement in dysphagia and incidence of future food bolus impaction in those patients treated with early esophageal dilation. Our aim is to determine if esophageal dilation and standard drug therapy improves symptoms of dysphagia. We also plan to obtain and store esophageal biopsy specimens for future immunologic assessment to help determine the underlying pathophysiology Eosinophilic Esophagitis.
- Conditions
- Suspected Eosinophilic Esophagitis
- Being tested
- Esophageal dilation, Steroid and Proton Pump Inhibitor Therapy
- Keywords
- eosinophilic esophagitis, esophageal food impaction, 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.
Esophageal dilationProcedure or surgery
Also called esophageal stretching
The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.
Steroid and Proton Pump Inhibitor TherapyDrug
Also called fluticasone, dexilant
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Group A receives steroids and PPI, (SOC) and esophageal dilation. Receives: Procedure: Esophageal dilation; Drug: Steroid and Proton Pump Inhibitor Therapy |
| B | Sham comparator | Receives steroids and PPI only- Does not have esophageal dilation. Receives: Drug: Steroid and Proton Pump Inhibitor Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)
Dysphagia Scores:
0 = able to eat normal diet / no dysphagia.
- = able to swallow some solid foods
- = able to swallow only semi solid foods
- = able to swallow liquids only
- = unable to swallow anything / total dysphagia
Measured: 60 days
Secondary outcomes (1)
Immunological Assessment Into the Etiology of Eosinophilic Esophagitis
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suspected 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Michael Vaezi, Vanderbilt University
- Investigators
- Michael F Vaezi, MD,PhD, MS epi, Principal investigator, vanderbilt Universtiy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880906
- Sponsor's protocol ID
- 080741
- Acronym
- EOE
- Status last verified
- Oct 2017
- First submitted
- 25 Aug 2008
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Blinded, Randomized Controlled Trial With Sham Comparing Standard Therapy With or Without Esophageal Dilatation in Patients With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT00880906
- Acronym / sponsor ID
- EOE / 080741
- Conditions
- Suspected Eosinophilic Esophagitis
- Keywords
- eosinophilic esophagitis, esophageal food impaction, dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Aug 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Posted 26 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for patients who have had a food impaction and/or difficulty swallowing, who are scheduled to have endoscopy, biopsy and possibly dilatation (stretching) of the esophagus.
Standard treatment for people who have food impaction and difficulty swallowing is endoscopy to view the esophagus, tissue biopsies of the lining of the esophagus for diagnosis, and drug therapy including steroids and drugs used to treat reflux disease. Early dilatation or stretching of the esophagus may be done at this time but not always. Some doctors prefer to wait and see if the drugs are affective.
It is not known if dilating the esophagus early in treatment adds benefit. Therefore, we are doing this study to compare the two methods of treatment. We will compare two groups: one group will have dilatation performed during the first endoscopy and one group will not have dilatation performed during endoscopy. We will see if dilatation helps prevent food impaction and improves swallowing.
Another purpose of this study is to learn more about the causes of swallowing problems, thus extra biopsies will be taken of the esophagus and store them for future research.
Detailed description
Eosinophilic esophagitis (EE) is an inflammatory condition of the esophagus found in the pediatric and adult population. It is characterized by an intense eosinophilic infiltration of the surface lining of the esophagus. EE is becoming an increasingly recognized diagnosis in individuals presenting with food bolus impaction and dysphagia. A history of chronic solid food dysphagia, food impaction and young age have all been noted characteristics in those patients subsequently diagnosed with EE. Eosinophilic esophagitis can be suspected by clinical presentation but histologic confirmation is necessary for a definitive diagnosis. The finding of large numbers of eosinophils (>15 per high powered field) on biopsy specimens are needed to confirm EE. Endoscopic features such as mucosal rings, linear furrows, proximal strictures and white esophageal papules have all been described in patients with EE.
The underlying pathophysiology of EE is poorly understood but is thought to be associated with a TH2-type allergic inflammatory response. Other studies have also suggested that immune dysregulation may play a role in the underlying pathophysiology of this disorder.
The optimal treatment of EE has not been determined. There have been studies noting that swallowed fluticasone propionate (FP), an inhaled corticosteroid, has shown benefit in adult and pediatric patients with EE. Esophageal dilation has been used in patients with EE with persistent dysphagia and food impaction. No study has evaluated the improvement in dysphagia and incidence of future food bolus impaction in those patients treated with early esophageal dilation. Our aim is to determine if esophageal dilation and standard drug therapy improves symptoms of dysphagia. We also plan to obtain and store esophageal biopsy specimens for future immunologic assessment to help determine the underlying pathophysiology Eosinophilic Esophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Esophageal dilation, Drug: Steroid and Proton Pump Inhibitor TherapyGroup A receives steroids and PPI, (SOC) and esophageal dilation. |
| B | Sham comparator | Drug: Steroid and Proton Pump Inhibitor TherapyReceives steroids and PPI only- Does not have esophageal dilation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female volunteers ≥18 years old.
- Patients with known or suspected Eosinophilic Esophagitis.
- Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia.
Key exclusion criteria (4 listed)
- Use of oral corticosteroids.
- Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety.
- Contraindication to esophageal dilation based on investigator's judgment.
- Esophageal motility abnormalities not thought to be related to 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal dilationAlso: esophageal stretchingThe esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation. | Procedure or surgery | A |
| Steroid and Proton Pump Inhibitor TherapyAlso: fluticasone, dexilant | Drug | A, B |
Primary outcome
Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)
Time frame: 60 days
Dysphagia Scores: 0 = able to eat normal diet / no dysphagia. 1. = able to swallow some solid foods 2. = able to swallow only semi solid foods 3. = able to swallow liquids only 4. = unable to swallow anything / total dysphagia
1 secondary outcome
Immunological Assessment Into the Etiology of Eosinophilic Esophagitis
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Michael F Vaezi, MD,PhD, MS epi principal investigator
vanderbilt Universtiy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal dilation and Steroid and Proton Pump Inhibitor Therapy in people with Suspected Eosinophilic Esophagitis, run by Vanderbilt University 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 4 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 6 Nov 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 26 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE) (time frame: 60 days). 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 6 Nov 2017.