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
Recruitment status was Recruiting
Sponsor:
Mahidol University
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 15, 2010 | ||||||||
| Last Updated Date | July 15, 2010 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms | ||||||||
| Official Title ICMJE | Prevalence of Positive Reactions in Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms | ||||||||
| Brief Summary | Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal symptoms |
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| 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 |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Food Allergy | ||||||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | 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 |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | March 2011 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 1 Month to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Thailand | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01164293 | ||||||||
| Other Study ID Numbers ICMJE | 079/2553(EC1) | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Mahidol University | ||||||||
| Study Sponsor ICMJE | Mahidol University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Mahidol University | ||||||||
| Verification Date | July 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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