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Completed

NCT Number: NCT01164293

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

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

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Key information

Conditions

Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Pediatrics, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Fin chamber

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: APT

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jul 16, 2010
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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