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

Mahidol University

Status and phase: Completed; Phase 1

Conditions: Food Allergy

Treatments: Device: Atopy patch test with food allergen

Study type: Interventional

Funder types: Other

Identifiers

NCT01164293

079/2553(EC1)

Details and patient eligibility

About

Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal symptoms

Full 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

Enrollment: 40 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Atopy patch test

Experimental group

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

Treatment:

Device: Atopy patch test with food allergen