- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01164293
Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms (APT)
Prevalence of Positive Reactions in Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Bangkok, Thailand, 10700
- Department of Pediatrics, Siriraj hospital, Mahidol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Atopy patch test
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
|
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)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms
Time Frame: 3 days
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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.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen
Time Frame: 3 days
|
To evaluate (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts.
(iv)Side effect or adverse events of APT
|
3 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nualanong Visitsunthorn, MD, Mahidol University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 079/2553(EC1)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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