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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

November 6, 2006

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Allergic reactions to wine

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00163735 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Positive basophil activiation test to wines

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study

Condition ^ICMJE

Food Allergy
Anaphylaxis

Intervention ^ICMJE

Drug: Administration of wine fined with potential food allergens

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Robyn E O'Hehir, MBBS FRACP PhD

++613 9276 2251

r.ohehir@alfred.org.au

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00163735

Responsible Party

Study ID Numbers ^ICMJE

124/02, Number 124/02

Study Sponsor ^ICMJE

Bayside Health

Collaborators ^ICMJE

Australian Wine Research Institute
National Health and Medical Research Council, Australia
The Alfred

Investigators ^ICMJE

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

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