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

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

This study is currently recruiting participants.
Verified by Bayside Health, September 2005

Sponsors and Collaborators:	Bayside Health The Australian Wine Research Institute, Adelaide National Health and Medical Research Council, Australia The Alfred
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00163735

Purpose

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.

Condition	Intervention
Food Allergy Anaphylaxis	Drug: Administration of wine fined with potential food allergens

MedlinePlus related topics:

Allergy Food Allergy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study

Official Title:	Potential Allergens in Wine: Double Blind Placebo-Controlled Trial and Basophil Activation Analysis

Further study details as provided by Bayside Health:

Primary Outcome Measures:

Allergic reactions to wine

Secondary Outcome Measures:

Positive basophil activiation test to wines

Estimated Enrollment:	40
Study Start Date:	August 2002
Estimated Study Completion Date:	August 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163735

Contacts


Contact: Robyn E O'Hehir, MBBS FRACP PhD	++613 9276 2251	r.ohehir@alfred.org.au

Locations


Australia, Victoria
	AIR Med, Alfred Hospital	Recruiting
	Melbourne, Victoria, Australia, 3004
	Contact: Robyn E OHehir, MBBS PhD FRACP ++6139276 2251 r.ohehir@alfred.org.au
	Principal Investigator: Robyn E O'Hehir, MBBS FRACP PhD

Sponsors and Collaborators

Bayside Health

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

More Information

Study ID Numbers:	124/02, Number 124/02
First Received:	September 12, 2005
Last Updated:	November 6, 2006
ClinicalTrials.gov Identifier:	NCT00163735
Health Authority:	Australia: Human Research Ethics Committee