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

NCT01164293 | Completed Phase 1 DMC

• 1 other identifier: 079/2553(EC1)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Food Allergy

Keywords

Atopy patch test

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen

  3 days

Study Arms (1)

Atopy patch test

EXPERIMENTAL

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

Device: Atopy patch test with food allergen

Interventions

Atopy patch test with food allergen 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)

Also known as: Fin chamber

Atopy patch test

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Pediatrics, Siriraj hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (1)

• 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.

  PMID: 27979025 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nualanong Visitsunthorn, MD

  Mahidol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

TH (1)