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

Prevalence of Positive Reactions in Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01164293
Acronym
APT
Enrollment
40
Registered
2010-07-16
Start date
2010-04-30
Completion date
2011-03-31
Last updated
2015-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy

Keywords

Atopy patch test

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

Interventions

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)

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms3 daysTo 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

MeasureTime frameDescription
Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen3 daysTo evaluate (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse events of APT

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026