NCT02227836

Brief Summary

This study is being done to see if allergy patch testing (APT) can help predict effective dietary therapy in patients with eosinophilic esophagitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

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

August 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 17, 2019

Completed
Last Updated

April 17, 2019

Status Verified

March 1, 2019

Enrollment Period

3.1 years

First QC Date

August 26, 2014

Results QC Date

March 1, 2019

Last Update Submit

March 25, 2019

Conditions

Eosinophilic Esophagitis

Keywords

Allergy Patch testingEosinophilic EsophagitisEoE

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of Patch Testing

    Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings

    up to 120 hours after application of patch test

Study Arms (1)

Allergy Patch Testing APT

EXPERIMENTAL

Patient will undergo APT testing per the following protocol: * 2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back. * Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits * The patches will be removed at 48 hours, and results read at 72 and 120 hours after application * Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).

Device: Allergy Patch Testing

Interventions

Allergy Patch TestingDEVICE
Also known as: APT, Patch testing, Allergy testing
Allergy Patch Testing APT

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ages 18-90
  • Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field (eos per HPF) on index esophageal biopsy
  • Persistent symptoms and/or greater than or equal to 10 eos per HPF on esophageal biopsy after at least 8 weeks of twice daily PPI therapy

You may not qualify if:

  • Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
  • Topical swallowed steroids within 8 weeks of study enrollment
  • Dermatologic conditions precluding application of Finn chambers to the skin for APT
  • 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

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Eckmann JD, Ravi K, Katzka DA, Davis DR, See JA, Geno DR, Kryzer LA, Alexander JA. Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study. Dig Dis Sci. 2018 Mar;63(3):694-702. doi: 10.1007/s10620-018-4928-4. Epub 2018 Jan 18.

    PMID: 29349695BACKGROUND

Related Links

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Patch TestsSkin Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Results Point of Contact

Title
Karthik Ravi, MD
Organization
Mayo Clinic
Ravi.Karthik@mayo.edu
507-284-4824

Study Officials

  • Karthik Ravi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 28, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 17, 2019

Results First Posted

April 17, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)