Food AllergyNCT00163735
Potential Allergens in Wine: Double-blind Placebo-controlled Trial
A study testing Administration of wine fined with potential food allergens in people with Food Allergy and Anaphylaxis, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy, Anaphylaxis
- What is being tested?
- Administration of wine fined with potential food allergens
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2002to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with IgE-mediated food allergy to milk, fish, egg or nuts Otherwise no major medical problems Able to drink wine -
Who cannot join
- Major asthma or cardiac disease Unwilling or unable to participate
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Allergens in Wine: Double Blind Placebo-controlled Trial and Basophil Activation Analysis
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.
Read the 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.
- Conditions
- Food Allergy, Anaphylaxis
- Being tested
- Administration of wine fined with potential food allergens
- Keywords
- Food allergy, wine, milk allergy, egg allergy, nut allergy, fish allergy
- Medical subject headings
- Food Hypersensitivity, Anaphylaxis, Milk Hypersensitivity, Egg Hypersensitivity, Nut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of wine fined with potential food allergensDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic reactions to wine
Secondary outcomes (1)
Positive basophil activiation test to wines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Australian Wine Research Institute, National Health and Medical Research Council, Australia, The Alfred
- Responsible party
- Sponsor
- Investigators
- Robyn E O'Hehir, MBBS PhD FRACP, Study director, Alfred Hospital and Monash UniversityJennifer M Rolland, PhD, Principal investigator, Monash UniversityCreina S Stockley, PhD, Principal investigator, The Australian Wine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163735
- Sponsor's protocol ID
- 124/02
- Other IDs
- Number 124/02
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 5 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Allergens in Wine: Double Blind Placebo-controlled Trial and Basophil Activation Analysis
- ClinicalTrials.gov ID
- NCT00163735
- Acronym / sponsor ID
- 124/02
- Conditions
- Food Allergy, Anaphylaxis
- Keywords
- Food allergy, wine, milk allergy, egg allergy, nut allergy, fish allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Australian Wine Research Institute, National Health and Medical Research Council, Australia, The Alfred
- Study start
- Aug 2002
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with IgE-mediated food allergy to milk, fish, egg or nuts Otherwise no major medical problems Able to drink wine -
Key exclusion criteria (2 listed)
- Major asthma or cardiac disease Unwilling or unable to participate
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of wine fined with potential food allergens | Drug | – |
Primary outcome
Allergic reactions to wine
1 secondary outcome
Positive basophil activiation test to wines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn E O'Hehir, MBBS PhD FRACP study director
Alfred Hospital and Monash University
Jennifer M Rolland, PhD principal investigator
Monash University
Creina S Stockley, PhD principal investigator
The Australian Wine Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of wine fined with potential food allergens in people with Food Allergy and Anaphylaxis, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergic reactions to wine. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013.