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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01164293
First received: July 15, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted

July 15, 2010
July 15, 2010
April 2010
December 2010   (final data collection date for primary outcome measure)
Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms [ Time Frame: 3 days ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
To evaluate (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse events of APT
Same as current
Not Provided
Not Provided
 
Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms
Prevalence of Positive Reactions in 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

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

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Food Allergy
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
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
Intervention: Device: Atopy patch test with food allergen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
1 Month to 18 Years
No
Contact: Onsuree Boonyaviwat, MD 66-8-1-7559939 onsuree@hotmail.com
Contact: Naulanong Visitsunthorn, MD 66-2-4197000 ext 5941 sinvs@mahidol.ac.th
Thailand
 
NCT01164293
079/2553(EC1)
Yes
Mahidol University
Mahidol University
Not Provided
Study Director: Nualanong Visitsunthorn, MD Mahidol University
Mahidol University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP