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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 19, 2013