NCT02434705

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

8.7 years

First QC Date

April 30, 2015

Last Update Submit

December 8, 2023

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (1)

  • Dilated intercellular spaces (spongiosis)

    one year

Study Arms (1)

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.

Other: Antigen (wheat base soy sauce) spray

Interventions

Antigen (wheat base soy sauce) sprayOTHER

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.

Also known as: Wheat based soy sauce
Antigen (wheat base soy sauce) spray

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Eosinophilic Esophagitis patients

You may qualify if:

  • 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.

You may not qualify if:

  • Acute allergy to wheat or soy
  • Currently taking steroids
  • Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Antigens

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

  • Joseph Murray, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 5, 2015

Study Start

April 1, 2015

Primary Completion

December 8, 2023

Study Completion

December 8, 2023

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

US(1)