Eosinophilic EsophagitisEoENCT02434705
Food Antigen in Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
The relationship or effect of food antigen (wheat based soy sauce) in eosinophilic esophagitis. It is believed that when food antigens are exposed to the esophageal tissue it starts an chronic allergy-based inflammation. This will be analyzed with the esophageal biopsies and the mucosal impedance probe. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Antigen (wheat base soy sauce) spray
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 8 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eosinophilic Esophagitis patients
Who may be able to join
- Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors.
- Patients previously diagnosed with Eosinophilic Esophagitis and are now in histologic remission due to treatment and have <15 eos hpf.
Who cannot join
- Acute allergy to wheat or soy
- Currently taking steroids
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis
The relationship or effect of food antigen (wheat based soy sauce) in eosinophilic esophagitis. It is believed that when food antigens are exposed to the esophageal tissue it starts an chronic allergy-based inflammation. This will be analyzed with the esophageal biopsies and the mucosal impedance probe.
Read the detailed description
One of the putative mechanisms of eosinophilic esophagitis is exposure of food antigens to antigen recognition cells in the esophageal mucosa that initiates a chronic allergy-based inflammatory response . It is believed that this exposure is facilitated through dilation of the intercellular spaces (DIS) between esophageal epithelial cells (termed spongiosis). This is substantiated by several studies which have demonstrated that: first, DIS is commonly found in biopsies from patients with active EoE and reverses with steroid therapy; second, DIS correlates to physiologic demonstration of increased esophageal epithelial permeability as shown through transepithelial small molecule flux in mucosal biopsies appraised in Ussing chambers and increased conductivity of electric current as measured in a mucosal impedance probe (Katzka, et al., in press, Clin Gastroenterol Hepatol). Although these mechanisms make intuitive sense, no one has shown the presence of food antigen in esophageal mucosa after ingestion and the correlation of this presence to dilation of intercellular spaces.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Antigen (wheat base soy sauce) spray
- Keywords
- Eosinophilic
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antigen (wheat base soy sauce) sprayOther
Also called Wheat based soy sauce
Patients having a clinically indicated endoscopy for Eosinphilic Esophagitis will have two biopsies from the esophageal body, 10 cm above the gastroesophageal junction. After biopsies are taken, approximately 10 cc of wheat based soy sauce will be sprayed though an endoscopic catheter onto the esophageal mucosa. The endoscopic examination will be completed and Two additional endoscopic biopsies will be taken 10 cm above the gastroesophageal junction.
| Study group | Role | What they receive |
|---|---|---|
| Antigen (wheat base soy sauce) spray | 1. Ten patients with active and ten with inactive eosinophilic esophagitis (defined by consensus guidelines) undergoing clinically indicated endoscopy and esophageal biopsies will participate in this study.
2. During the endoscopy two biopsies will be taken from the esophageal body, 10 cm above the gastroesophageal junction.
3. After biopsies are taken, approximately 10 cc of wheat based soy sauce (antigen spray) will be sprayed though an endoscopic catheter onto the esophageal mucosa. The endoscopic examination will be completed and two additional endoscopic biopsies will be taken 10 cm above the gastroesophageal junction. Receives: Other: Antigen (wheat base soy sauce) spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Gluten and Soy Antigen in Esophageal Mucosa
Cryosectioning of the frozen esophageal tissue will then be done for immunofluorescent staining to determine the distribution/localization of different cells and dietary proteins We will use anti-gliadin (Biorbyt catalog # orb157160)and anti-soy (LifeSpan Biosciences Catalog # LS-C132165-100)antibodies against cell surface markers as well as dietary proteins/peptides tagged with different fluorochromes to achieve this.
Measured: one year
Secondary outcomes (1)
Dilated intercellular spaces (spongiosis)
Is graded on the basis of the worst area, using a 0-4+ scale [3]. DIS grading was assessed by the appearance of the tight junctions seen on biopsy and the degree of widening between epithelial cells . Grade 0: no intercellular space widening and intact tight junctions. Grade 1: mild widening of intercellular spaces with attenuation and prominence of tight junctions. Grade 2: Further widening of intercellular space with some disruption of tight junctions. Grade 3: complete disruption of tight junctions with further widening of intercellular spaces, forming small "lakes" in the epithelium. Grade 4: Coalescence of epithelial lakes.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study start1 Apr 2015
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph A. Murray, M.D., Mayo Clinic
- Investigators
- Joseph Murray, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434705
- Sponsor's protocol ID
- 15-000883
- Acronym
- EoE
- Status last verified
- Dec 2023
- First submitted
- 30 Apr 2015
- Last updated
- 12 Dec 2023
- 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT02434705
- Acronym / sponsor ID
- EoE / 15-000883
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 5 May 2015 (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 relationship or effect of food antigen (wheat based soy sauce) in eosinophilic esophagitis. It is believed that when food antigens are exposed to the esophageal tissue it starts an chronic allergy-based inflammation. This will be analyzed with the esophageal biopsies and the mucosal impedance probe.
Detailed description
One of the putative mechanisms of eosinophilic esophagitis is exposure of food antigens to antigen recognition cells in the esophageal mucosa that initiates a chronic allergy-based inflammatory response . It is believed that this exposure is facilitated through dilation of the intercellular spaces (DIS) between esophageal epithelial cells (termed spongiosis). This is substantiated by several studies which have demonstrated that: first, DIS is commonly found in biopsies from patients with active EoE and reverses with steroid therapy; second, DIS correlates to physiologic demonstration of increased esophageal epithelial permeability as shown through transepithelial small molecule flux in mucosal biopsies appraised in Ussing chambers and increased conductivity of electric current as measured in a mucosal impedance probe (Katzka, et al., in press, Clin Gastroenterol Hepatol). Although these mechanisms make intuitive sense, no one has shown the presence of food antigen in esophageal mucosa after ingestion and the correlation of this presence to dilation of intercellular spaces.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antigen (wheat base soy sauce) spray | – | Other: Antigen (wheat base soy sauce) spray1. Ten patients with active and ten with inactive eosinophilic esophagitis (defined by consensus guidelines) undergoing clinically indicated endoscopy and esophageal biopsies will participate in this study. 2. During the endoscopy two biopsies will be taken from the esophageal body, 10 cm above the gastroesophageal junction. 3. After biopsies are taken, approximately 10 cc of wheat based soy sauce (antigen spray) will be sprayed though an endoscopic catheter onto the esophageal mucosa. The endoscopic examination will be completed and two additional endoscopic biopsies will be taken 10 cm above the gastroesophageal junction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eosinophilic Esophagitis patients
Key inclusion criteria (2 listed)
- Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors.
- Patients previously diagnosed with Eosinophilic Esophagitis and are now in histologic remission due to treatment and have <15 eos hpf.
Key exclusion criteria (3 listed)
- Acute allergy to wheat or soy
- Currently taking steroids
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
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 |
|---|---|---|
| Antigen (wheat base soy sauce) sprayAlso: Wheat based soy saucePatients having a clinically indicated endoscopy for Eosinphilic Esophagitis will have two biopsies from the esophageal body, 10 cm above the gastroesophageal junction. After biopsies are taken, approximately 10 cc of wheat based soy sauce will be sprayed though an endoscopic catheter onto the esophageal mucosa. The endoscopic examination will be completed and Two additional endoscopic biopsies will be taken 10 cm above the gastroesophageal junction. | Other | Antigen (wheat base soy sauce) spray |
Primary outcome
Measurement of Gluten and Soy Antigen in Esophageal Mucosa
Time frame: one year
Cryosectioning of the frozen esophageal tissue will then be done for immunofluorescent staining to determine the distribution/localization of different cells and dietary proteins We will use anti-gliadin (Biorbyt catalog # orb157160)and anti-soy (LifeSpan Biosciences Catalog # LS-C132165-100)antibodies against cell surface markers as well as dietary proteins/peptides tagged with different fluorochromes to achieve this.
1 secondary outcome
Dilated intercellular spaces (spongiosis)
Time frame: one 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 12 Dec 2023.
- 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.
Joseph Murray, 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 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 12 Dec 2023. 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?
Measurement of Gluten and Soy Antigen in Esophageal Mucosa (time frame: one 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 12 Dec 2023.