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Potential Allergens in Wine: Double-blind Placebo-controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163735
First Posted: September 14, 2005
Last Update Posted: December 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Australian Wine Research Institute
National Health and Medical Research Council, Australia
The Alfred
Information provided by (Responsible Party):
Bayside Health
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Potential Allergens in Wine: Double Blind Placebo-controlled Trial and Basophil Activation Analysis

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Allergic reactions to wine

Secondary Outcome Measures:
  • Positive basophil activiation test to wines

Enrollment: 48
Study Start Date: August 2002
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163735


Locations
Australia, Victoria
AIR Med, Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Australian Wine Research Institute
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

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00163735     History of Changes
Other Study ID Numbers: 124/02
Number 124/02
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: December 5, 2013
Last Verified: September 2005

Keywords provided by Bayside Health:
Food allergy
wine
milk allergy
egg allergy
nut allergy
fish allergy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Anaphylaxis
Immune System Diseases
Hypersensitivity, Immediate