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CompletedNCT01164293APTUpdated Sep 18, 2015

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

A Phase 1 interventional study of Atopy patch test with food allergen in Food Allergy, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2015-09-18.

Sponsored by Mahidol University · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
1 Month to 18 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Food Allergy

Keywords

  • Atopy patch test
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 40 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

Interventions

  • DeviceAtopy 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)

    Also known as: Fin chamber

06

What researchers measure

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.

    Time frame: 3 days

Secondary outcomes

  1. 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

    Time frame: 3 days

07

Study locations

1 site
  • Department of Pediatrics, Siriraj hospital, Mahidol University
    Bangkok, 10700, Thailand
08

References and documents

Publications

  • 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. PubMed 27979025 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01164293
Lead sponsor
Mahidol University
Responsible party
Nualanong Visitsunthorn (Professor, Mahidol University) — Principal investigator
First posted
Jul 16, 2010
Start date
Apr 2010
Primary completion
Dec 2010
Completion
Mar 2011
Last update
Sep 18, 2015

Study contacts

Nualanong Visitsunthorn, MD
study director · Mahidol University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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