Eosinophilic EsophagitisNCT02599558
Cytosponge and Dietary Therapy in EoE
A study testing Cytosponge in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to see if the investigators can use only the cytosponge ( A 10 minute, in office procedure that does not require sedation) to replace the 6-10 endoscopies routinely perform during dietary restriction and food reintroduction in EoE? Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Cytosponge
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 8 Jan 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf and failed to respond to the PPI therapy
- Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk
Who cannot join
- Clinical evidence of infectious process potentially contributing to dysphagia ( candidiasis, CMV, herpes)
- Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
- Esophageal minimal diameter < 13 mm on structured barium esophagram
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Trial of Dietary Therapy Directed by the Esophageal Sponge in the Management of Eosinophilic Esophagitis.
This study is being done to see if the investigators can use only the cytosponge ( A 10 minute, in office procedure that does not require sedation) to replace the 6-10 endoscopies routinely perform during dietary restriction and food reintroduction in EoE?
Read the detailed description
Dietary Therapy has been shown to be successful in the treatment of adult and pediatric patients with eosinophilic esophagitis Dietary studies were initially reported in children, but the results appear to be similar in adult patients. Elemental diets are successful in 70-95% of patients but are poorly tolerated. A six food elimination diet has been effective in about 70% of adult patients with EoE . In these adult studies skin prick testing was not helpful in predicting which foods would lead to a flare of disease when reintroduced into the diet. Therefore, the current standard of care requires multiple EGDs with esophageal biopsy during the dietary restriction and reintroduction phases of this study. Since the investigators are making lifelong dietary decisions during this process of food reintroduction, it is imperative the investigators be accurate. Unfortunately, these multiple EGDs have significant cost and are invasive procedures with some risk. Moreover, there is significant indirect costs with travel and time off work for the patients and drivers. Previous studies have found the esophageal sponge to be an accurate technique of accessing esophageal eosinophilia in EoE . The sponge is swallowed as a 12 mm capsule on a string. The capsule rapidly dissolves upon entering the stomach and the sponge then expands and can be pulled out the mouth five minutes after ingestion. In previous studies, the procedure was very well tolerated and all patients preferred the sponge to endoscopy.
Therefore the sponge is a well tolerated, inexpensive, very low risk procedure that would be an ideal option to replace EGD esophageal sampling in the evaluation of dietary treatment of EoE.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Cytosponge
- Keywords
- EOE
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytospongeDevice
Also called sponge
A capsule with a string attached with a sponge inside is swallowed. The string is held without any tension to allow the capsule to move into the stomach. The string will be held for five minutes to allow the capsule to dissolve in the stomach; a round mesh sponge about the size of a quarter is released.
| Study group | Role | What they receive |
|---|---|---|
| Cytosponge-directed food reintroduction | Experimental | Subjects will follow the six-food elimination diet per clinical protocol. The cytosponge will be used to monitor the diet at certain timepoints during food reintroduction Receives: Device: Cytosponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Remission by Sponge Cytology
Number of subject's sponge cytology to accurately detect histological remission when compared with standard of care EGD (defined as a peak eosinophil count of <15 eos/hpf on endoscopic biopsy)
Measured: approximately 4 weeks post food reintroduction
Secondary outcomes (1)
Eosinophilic Esophagitis Activity Index Patient Reported Outcomes (EEsAI PRO) Score
The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). A PRO < 20 defines asymptomatic EoE
Measured: approximately 4 weeks post food reintroduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion8 Jan 2022
- Study completion8 Jan 2022
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.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT02599558
- Sponsor's protocol ID
- 15-004741
- Status last verified
- Dec 2022
- First submitted
- 2 Nov 2015
- Last updated
- 30 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Alexander JA, Ravi K, Symrk TC, Wu TT, Lavey CJ, Geno D, Johnson AJ, Lennon RJ, Collins MH, Dellon ES, Katzka DA. Use of the Esophageal Sponge in Directing Food Reintroduction in Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):299-306.e3. doi: 10.1016/j.cgh.2022.05.029. Epub 2022 Jun 10.
PubMed 35697266
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Dietary Therapy Directed by the Esophageal Sponge in the Management of Eosinophilic Esophagitis.
- ClinicalTrials.gov ID
- NCT02599558
- Acronym / sponsor ID
- 15-004741
- Conditions
- Eosinophilic Esophagitis
- Keywords
- EOE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 8 Jan 2022 (actual)
- Study completion
- 8 Jan 2022 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Posted 30 Dec 2022
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 being done to see if the investigators can use only the cytosponge ( A 10 minute, in office procedure that does not require sedation) to replace the 6-10 endoscopies routinely perform during dietary restriction and food reintroduction in EoE?
Detailed description
Dietary Therapy has been shown to be successful in the treatment of adult and pediatric patients with eosinophilic esophagitis Dietary studies were initially reported in children, but the results appear to be similar in adult patients. Elemental diets are successful in 70-95% of patients but are poorly tolerated. A six food elimination diet has been effective in about 70% of adult patients with EoE . In these adult studies skin prick testing was not helpful in predicting which foods would lead to a flare of disease when reintroduced into the diet. Therefore, the current standard of care requires multiple EGDs with esophageal biopsy during the dietary restriction and reintroduction phases of this study. Since the investigators are making lifelong dietary decisions during this process of food reintroduction, it is imperative the investigators be accurate. Unfortunately, these multiple EGDs have significant cost and are invasive procedures with some risk. Moreover, there is significant indirect costs with travel and time off work for the patients and drivers. Previous studies have found the esophageal sponge to be an accurate technique of accessing esophageal eosinophilia in EoE . The sponge is swallowed as a 12 mm capsule on a string. The capsule rapidly dissolves upon entering the stomach and the sponge then expands and can be pulled out the mouth five minutes after ingestion. In previous studies, the procedure was very well tolerated and all patients preferred the sponge to endoscopy.
Therefore the sponge is a well tolerated, inexpensive, very low risk procedure that would be an ideal option to replace EGD esophageal sampling in the evaluation of dietary treatment of EoE.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytosponge-directed food reintroduction | Experimental | Device: CytospongeSubjects will follow the six-food elimination diet per clinical protocol. The cytosponge will be used to monitor the diet at certain timepoints during food reintroduction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf and failed to respond to the PPI therapy
- Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk
Key exclusion criteria (3 listed)
- Clinical evidence of infectious process potentially contributing to dysphagia ( candidiasis, CMV, herpes)
- Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
- Esophageal minimal diameter < 13 mm on structured barium esophagram
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 |
|---|---|---|
| CytospongeAlso: spongeA capsule with a string attached with a sponge inside is swallowed. The string is held without any tension to allow the capsule to move into the stomach. The string will be held for five minutes to allow the capsule to dissolve in the stomach; a round mesh sponge about the size of a quarter is released. | Device | Cytosponge-directed food reintroduction |
Primary outcome
Histological Remission by Sponge Cytology
Time frame: approximately 4 weeks post food reintroduction
Number of subject's sponge cytology to accurately detect histological remission when compared with standard of care EGD (defined as a peak eosinophil count of <15 eos/hpf on endoscopic biopsy)
1 secondary outcome
Eosinophilic Esophagitis Activity Index Patient Reported Outcomes (EEsAI PRO) Score
Time frame: approximately 4 weeks post food reintroduction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35697266Alexander JA, Ravi K, Symrk TC, Wu TT, Lavey CJ, Geno D, Johnson AJ, Lennon RJ, Collins MH, Dellon ES, Katzka DA. Use of the Esophageal Sponge in Directing Food Reintroduction in Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):299-306.e3. doi: 10.1016/j.cgh.2022.05.029. Epub 2022 Jun 10.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Pub MedLink provided by the sponsor.
Related trials for Eosinophilic Esophagitis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis
Active, not recruitingPhase 2
A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
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?
A study testing Cytosponge in people with 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 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 30 Dec 2022. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2022). 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?
Histological Remission by Sponge Cytology (time frame: approximately 4 weeks post food reintroduction). 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 NCT02599558, which also lists 1 linked publication.
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 30 Dec 2022.