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

Primary Purpose

Food Allergy, Anaphylaxis

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Administration of wine fined with potential food allergens

About this trial

This is an interventional diagnostic trial for Food Allergy focused on measuring Food allergy, wine, milk allergy, egg allergy, nut allergy, fish allergy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

AIR Med, Alfred Hospital

Outcomes

Primary Outcome Measures

Allergic reactions to wine

Secondary Outcome Measures

Positive basophil activiation test to wines

Full Information

NCT ID

NCT00163735

First Posted

September 12, 2005

Last Updated

December 3, 2013

Sponsor

Bayside Health

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00163735

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

August 2002 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayside Health

Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Food Allergy, Anaphylaxis

Keywords

Food allergy, wine, milk allergy, egg allergy, nut allergy, fish allergy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Administration of wine fined with potential food allergens

Primary Outcome Measure Information:

Title

Allergic reactions to wine

Secondary Outcome Measure Information:

Title

Positive basophil activiation test to wines

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robyn E O'Hehir, MBBS PhD FRACP

Organizational Affiliation

Alfred Hospital and Monash University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jennifer M Rolland, PhD

Organizational Affiliation

Monash University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Creina S Stockley, PhD

Organizational Affiliation

The Australian Wine Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

AIR Med, Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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