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

Phase 1

Completed

• Conditions: Food Allergy
• Interventions: Device: Atopy patch test with food allergen

• Registration Number: NCT01164293
• Lead Sponsor: Mahidol University

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

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-17
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atopy patch test	Atopy patch test with food allergen	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

Primary Outcome Measures

Name	Time	Method
Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms	3 days	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

Name	Time	Method
Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen	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

Trial Locations

Locations (1)

Department of Pediatrics, Siriraj hospital, Mahidol University; 🇹🇭 Bangkok, Thailand