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

Food Allergy Clinical Trial

— APT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164293
• Other study ID #: 079/2553(EC1)
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2010
• Last updated: September 17, 2015
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: September 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Device:
• Atopy patch test with food allergen
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)

Locations

Country	Name	City	State
Thailand	Department of Pediatrics, Siriraj hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days	No
Secondary	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	3 days	Yes