Potential Allergens in Wine: Double-blind Placebo-control... | NCT00163735

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

NCT00163735

Sponsor

Bayside Health

Status

Completed

Last Update Posted

Dec 5, 2013Estimated

Enrollment

48Actual

Phase

Not Applicable

Conditions

Food Allergy
Anaphylaxis

Interventions

Administration of wine fined with potential food allergens

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Number 124/02

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2002

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2013

Last Update Posted Date

Dec 5, 2013Estimated

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

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Name	Type	Description	Arm Group Labels	Other Names
Administration of wine fined with potential food allergens	Drug

Measure	Description	Time Frame
Allergic reactions to wine

Measure	Description	Time Frame
Positive basophil activiation test to wines

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robyn E O'Hehir, MBBS PhD FRACP	Alfred Hospital and Monash University	Study Director
Jennifer M Rolland, PhD	Monash University	Principal Investigator
Creina S Stockley, PhD	The Australian Wine Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AIR Med, Alfred Hospital		Melbourne	Victoria	3004	Australia

Condition Browse Module

MeSH Terms

ID	Term
D005512	Food Hypersensitivity
D000707	Anaphylaxis
D016269	Milk Hypersensitivity
D021181	Egg Hypersensitivity
D021184	Nut Hypersensitivity

Ancestor Terms

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D000074924	Nut and Peanut Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided