Value of Patch Testing in Direct Diet Therapy for Eosinop... | NCT02227836

NCT02227836

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
UL1TR000135	U.S. NIH Grant/Contract		View source

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Allergy Patch Testing	Device		Allergy Patch Testing APT	APT Patch testing Allergy testing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Karthik Ravi, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29349695	Background	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.

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Allergy Patch Testing APT	Patient will undergo Atopy Patch Testing (APT) 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).

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Allergy Patch Testing APT	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).

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Count of Participants

Participants

up to 120 hours after application of patch test

ID	Title	Description
OG000	Allergy Patch Testing APT	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 hours after application. Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Allergy Patch Testing APT	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).

More Info Module

Certain Agreements

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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 30, 2014	Feb 28, 2019	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D057765	Eosinophilic Esophagitis

ID	Term
D004941	Esophagitis
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Intervention Browse Module

ID	Term
D010328	Patch Tests
D012882	Skin Tests

ID	Term
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis