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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | September 12, 2005 | ||||||||||||
| Last Updated Date | November 6, 2006 | ||||||||||||
| Start Date ICMJE | August 2002 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE |
Allergic reactions to wine | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00163735 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Positive basophil activiation test to wines | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Potential Allergens in Wine: Double-Blind Placebo-Controlled Trial | ||||||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study | ||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Administration of wine fined with potential food allergens | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Enrollment ICMJE | 40 | ||||||||||||
| Completion Date | August 2006 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | 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 - |
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 65 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Australia | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00163735 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | 124/02, Number 124/02 | ||||||||||||
| Study Sponsor ICMJE | Bayside Health | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Bayside Health | ||||||||||||
| Verification Date | September 2005 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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