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

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ClinicalTrials.gov Identifier: NCT01164293
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : September 18, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal symptoms

Condition or disease Intervention/treatment Phase
Food Allergy Device: Atopy patch test with food allergen Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Positive Reactions in Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms
Study Start Date : April 2010
Primary Completion Date : December 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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
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)
Other Name: Fin chamber


Outcome Measures

Primary Outcome Measures :
  1. Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms [ Time Frame: 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 :
  1. Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen [ Time Frame: 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


Eligibility Criteria

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164293


Locations
Thailand
Department of Pediatrics, Siriraj hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Study Director: Nualanong Visitsunthorn, MD Mahidol University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nualanong Visitsunthorn, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01164293     History of Changes
Other Study ID Numbers: 079/2553(EC1)
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015

Keywords provided by Nualanong Visitsunthorn, Mahidol University:
Atopy patch test

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate