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Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms (APT)

Primary Purpose

Food Allergy

Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Atopy patch test with food allergen
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Food Allergy focused on measuring Atopy patch test

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who had history of suspected food allergy-related gastrointestinal symptoms eg. nausea and vomiting, diarrhea, abdominal pain or hematochezia after ingesting some food.
  • Age 1 month-18 yrs
  • Elimination diet was done at least 7 days before starting the study
  • Written informed consent was obtained from the parents of each child enrolled in the study

Exclusion Criteria:

  • Who have dermographism
  • Who have chronic disease eg. autoimmune disease, immune deficiency, cancer or allergic disease
  • Pregnant women
  • Who have severe eczema
  • Who receive antihistamine, topical steroid and systemic steroid > 20 mg/day withiin 7 days prior study

Sites / Locations

  • Department of Pediatrics, Siriraj hospital, Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atopy patch test

Arm Description

Atopy patches were applied on food allergy patient's back for 48 hrs then the patches were removed. Reaction was evaluated at 48 and 72 hrs after applying atopy patch test

Outcomes

Primary Outcome Measures

Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms
To evaluate (i) The prevalence of positive reaction of APTs for food allergy-related gastrointestinal diseases. (ii)Positive reaction of APT compare with skin prick test.

Secondary Outcome Measures

Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen
To evaluate (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse events of APT

Full Information

First Posted
July 15, 2010
Last Updated
September 17, 2015
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01164293
Brief Title
Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms
Acronym
APT
Official Title
Prevalence of Positive Reactions in Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal symptoms
Detailed Description
The prevalence of food allergy seems to be increasing, which might explain the increased demand for reliable evaluation of patients with suspected food-related gastrointestinal symptoms. Little is known about the diagnostic accuracy of atopy patch tests(APT) in the clinical practice. APT seems to have a better specificity than the IgE methods and seems to reflect late-phase clinical reactions.The aims of this study were to evaluate: (i) The prevalence of positive reaction of APTs for food allergy-related gastrointestinal diseases. (ii)Positive reaction of APT compare with skin prick test. (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse events of APT

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
Atopy patch test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atopy patch test
Arm Type
Experimental
Arm Description
Atopy patches were applied on food allergy patient's back for 48 hrs then the patches were removed. Reaction was evaluated at 48 and 72 hrs after applying atopy patch test
Intervention Type
Device
Intervention Name(s)
Atopy patch test with food allergen
Other Intervention Name(s)
Fin chamber
Intervention Description
Atopy patches used with food lyophilized allergen and commercial allergen were placed on back of subjects for 48 hrs then atopy patches were taken off. Subjects should return to evaluate the reaction one day later (72 hr after applying atopy patch test)
Primary Outcome Measure Information:
Title
Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms
Description
To evaluate (i) The prevalence of positive reaction of APTs for food allergy-related gastrointestinal diseases. (ii)Positive reaction of APT compare with skin prick test.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen
Description
To evaluate (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse events of APT
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who had history of suspected food allergy-related gastrointestinal symptoms eg. nausea and vomiting, diarrhea, abdominal pain or hematochezia after ingesting some food. Age 1 month-18 yrs Elimination diet was done at least 7 days before starting the study Written informed consent was obtained from the parents of each child enrolled in the study Exclusion Criteria: Who have dermographism Who have chronic disease eg. autoimmune disease, immune deficiency, cancer or allergic disease Pregnant women Who have severe eczema Who receive antihistamine, topical steroid and systemic steroid > 20 mg/day withiin 7 days prior study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nualanong Visitsunthorn, MD
Organizational Affiliation
Mahidol University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Pediatrics, Siriraj hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
27979025
Citation
Visitsunthorn N, Chatpornvorarux S, Pacharn P, Jirapongsananuruk O. Atopy patch test in children with atopic dermatitis. Ann Allergy Asthma Immunol. 2016 Dec;117(6):668-673. doi: 10.1016/j.anai.2016.09.446.
Results Reference
derived

Learn more about this trial

Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms

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