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| Sponsors and Collaborators: |
Bayside Health Australian Wine Research Institute 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 |
| 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | August 2006 |
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 |
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| Contact: Robyn E O'Hehir, MBBS FRACP PhD | ++613 9276 2251 | r.ohehir@alfred.org.au |
| 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 | |
| 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 |
| Study First Received: | September 12, 2005 |
| Last Updated: | November 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00163735 History of Changes |
| Health Authority: | Australia: Human Research Ethics Committee |
|
Food allergy wine milk allergy |
egg allergy nut allergy fish allergy |
|
Food Hypersensitivity Hypersensitivity Milk Hypersensitivity |
Anaphylaxis Hypersensitivity, Immediate Egg Hypersensitivity |
|
Hypersensitivity Food Hypersensitivity Immune System Diseases Anaphylaxis Hypersensitivity, Immediate |
