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Trial record 4 of 84055 for:    testing

Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis (EoE)

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ClinicalTrials.gov Identifier: NCT02227836
Recruitment Status : Completed
First Posted : August 28, 2014
Results First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Karthik Ravi, M.D., Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Eosinophilic Esophagitis
Intervention Device: Allergy Patch Testing
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Allergy Patch Testing APT
Hide Arm/Group Description

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).
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Allergy Patch Testing APT
Hide Arm/Group Description

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).
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
43  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
Allergic history  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
7
  87.5%
1.Primary Outcome
Title Sensitivity of Patch Testing
Hide Description Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings
Time Frame up to 120 hours after application of patch test
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allergy Patch Testing APT
Hide Arm/Group Description:

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).
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
1
  12.5%
Time Frame Data were collected from baseline until 2 weeks after completion of the final study visit for each subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Allergy Patch Testing APT
Hide Arm/Group Description

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).
All-Cause Mortality
Allergy Patch Testing APT
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Allergy Patch Testing APT
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Allergy Patch Testing APT
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Karthik Ravi, MD
Organization: Mayo Clinic
Phone: 507-284-4824
Responsible Party: Karthik Ravi, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02227836     History of Changes
Other Study ID Numbers: 14-002050
UL1TR000135 ( U.S. NIH Grant/Contract )
First Submitted: August 26, 2014
First Posted: August 28, 2014
Results First Submitted: March 1, 2019
Results First Posted: April 17, 2019
Last Update Posted: April 17, 2019