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Potential Allergens in Wine: Double-Blind Placebo-Controlled Trial

This study is currently recruiting participants.
Study NCT00163735.   Last updated on November 6, 2006.   Information provided by Bayside Health

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Descriptive Information Fields
Brief Title  Potential Allergens in Wine: Double-Blind Placebo-Controlled Trial
Official Title  Potential Allergens in Wine: Double Blind Placebo-Controlled Trial and Basophil Activation Analysis
Brief Summary

This study is designed to identify whether wines which are produced using the common potential food allergens such as proteins derived from fish, milk or egg are likely to contain sufficient food allergens to cause allergic reactions in susceptible individuals.

Detailed Description

Recent international legislation requires labelling of wines made using potentially allergenic food proteins "casein", egg white, isinglass ( fish derived), milk or evaporated milk where "there is detectable residual processing aid". However it is not clear whether the final wine contains concentrations of residual added food proteins that can provoke allergic reactions.

Comparison:This study is a double blind, placebo-controlled trial to determine whether adults known to be allergic to eggs, fish, milk and/or nuts exhibit allergic reactions following consumption of Australian commercial wines fined with food allergens.

Study Phase
Study Type  Interventional
Study Design  Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Primary Outcome Measure  Allergic reactions to wine
Secondary Outcome Measure  Positive basophil activiation test to wines
Condition  Food Allergy
Anaphylaxis
Intervention  Drug: Administration of wine fined with potential food allergens
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  August 2002
Completion Date August 2006
Eligibility Criteria 

Inclusion Criteria:

Individuals with IgE-mediated food allergy to milk, fish, egg or nuts Otherwise no major medical problems Able to drink wine -

Exclusion Criteria:

Major asthma or cardiac disease Unwilling or unable to participate

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Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Robyn E O'Hehir, MBBS FRACP PhD     ++613 9276 2251     r.ohehir@alfred.org.au    
Location Countries  Australia
Administrative Information Fields
NCT ID  NCT00163735
Organization ID 124/02
Secondary IDs †† Number 124/02
Study Sponsor  Bayside Health
Collaborators †† The Australian Wine Research Institute, Adelaide
National Health and Medical Research Council, Australia
The Alfred
Investigators 
Study Director:     Robyn E O'Hehir, MBBS PhD FRACP     Alfred Hospital and Monash University    
Principal Investigator:     Jennifer M Rolland, PhD     Monash University    
Principal Investigator:     Creina S Stockley, PhD     The Australian Wine Research Institute    
Information Provided By Bayside Health
Verification Date September 2005
First Received Date  September 12, 2005
Last Updated Date November 6, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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