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

NCT ID: NCT01164293

Last Updated: 2015-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-03-31

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

Conditions

Food Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Atopy patch test with food allergen

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Other Intervention Names

Fin chamber

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Nualanong Visitsunthorn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nualanong Visitsunthorn, MD

Role: STUDY_DIRECTOR

Mahidol University

Locations

Department of Pediatrics, Siriraj hospital, Mahidol University

Bangkok, Bangkok, Thailand

Countries

Thailand

References

Visitsunthorn N, Chatpornvorarux S, Pacharn P, Jirapongsananuruk O. Atopy patch test in children with atopic dermatitis. Ann Allergy Asthma Immunol. 2016 Dec;117(6):668-673. doi: 10.1016/j.anai.2016.09.446.

Reference Type: DERIVED

PMID: 27979025 (View on PubMed)

Other Identifiers

079/2553(EC1)

Identifier Type: -

Identifier Source: org_study_id