|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||||||
| 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 | ||||||||||||
| 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 † | Interventional | ||||||||||||
| Study Design † | Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study | ||||||||||||
| Primary Outcome Measure † | Allergic reactions to wine | ||||||||||||
| Secondary Outcome Measure † | Positive basophil activiation test to wines | ||||||||||||
| Condition † | Food Allergy Anaphylaxis |
||||||||||||
| Intervention † | Drug: Administration of wine fined with potential food allergens | ||||||||||||
| MEDLINE PMIDs | |||||||||||||
| Links | |||||||||||||
| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Recruiting | ||||||||||||
| Enrollment † | 40 | ||||||||||||
| Start Date † | August 2002 | ||||||||||||
| Completion Date | August 2006 | ||||||||||||
| Eligibility 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 - |
||||||||||||
| Gender | Both | ||||||||||||
| Ages | 18 Years to 65 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts †† |
|
||||||||||||
| Location Countries † | Australia | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00163735 | ||||||||||||
| Organization ID | 124/02 | ||||||||||||
| Secondary IDs †† | Number 124/02 | ||||||||||||
| Study Sponsor † | Bayside Health | ||||||||||||
| Collaborators †† | The Australian Wine Research Institute, Adelaide National Health and Medical Research Council, Australia The Alfred |
||||||||||||
| Investigators † |
|
||||||||||||
| Information Provided By | Bayside Health | ||||||||||||
| Verification Date | September 2005 | ||||||||||||
| First Received Date † | September 12, 2005 | ||||||||||||
| Last Updated Date | November 6, 2006 | ||||||||||||