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
  Purpose

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


Condition Intervention Phase
Food Allergy
Device: Atopy patch test with food allergen
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prevalence of Positive Reactions in Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: April 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164293

Contacts
Contact: Onsuree Boonyaviwat, MD 66-8-1-7559939 onsuree@hotmail.com
Contact: Naulanong Visitsunthorn, MD 66-2-4197000 ext 5941 sinvs@mahidol.ac.th

Locations
Thailand
Department of Pediatrics, Siriraj hospital, Mahidol University Recruiting
Bangkok, Thailand
Contact: Onsuree Boonyaviwat, MD    66-8-1-7559939    onsuree@hotmail.com   
Contact: Naulanong Visitsunthorn, MD    66-2-4197000 ext 5941    sinvs@mahidol.ac.th   
Sub-Investigator: Onsuree Boonyaviwat, MD         
Principal Investigator: Naulanong Visitsunthorn, MD         
Sponsors and Collaborators
Mahidol University
Investigators
Study Director: Nualanong Visitsunthorn, MD Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01164293     History of Changes
Other Study ID Numbers: 079/2553(EC1)
Study First Received: July 15, 2010
Last Updated: July 15, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Atopy patch test

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Immune System Diseases
Hypersensitivity, Immediate
Digestive System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014