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Trial record 19 of 342 for:    "Food Allergy"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01164293
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : September 18, 2015
Sponsor:
Information provided by (Responsible Party):
Nualanong Visitsunthorn, Mahidol University

Tracking Information
First Submitted Date  ICMJE July 15, 2010
First Posted Date  ICMJE July 16, 2010
Last Update Posted Date September 18, 2015
Study Start Date  ICMJE April 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01164293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Arms  ICMJE 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2010)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01164293
Other Study ID Numbers  ICMJE 079/2553(EC1)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nualanong Visitsunthorn, Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nualanong Visitsunthorn, MD Mahidol University
PRS Account Mahidol University
Verification Date September 2015

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