NCT00163735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

December 5, 2013

Status Verified

September 1, 2005

Enrollment Period

3.8 years

First QC Date

September 12, 2005

Last Update Submit

December 3, 2013

Conditions

Food AllergyAnaphylaxis

Keywords

Food allergywinemilk allergyegg allergynut allergyfish allergy

Outcome Measures

Primary Outcomes (1)

  • Allergic reactions to wine

Secondary Outcomes (1)

  • Positive basophil activiation test to wines

Interventions

Administration of wine fined with potential food allergensDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with IgE-mediated food allergy to milk, fish, egg or nuts Otherwise no major medical problems Able to drink wine -

You may not qualify if:

  • Major asthma or cardiac disease Unwilling or unable to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIR Med, Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Food HypersensitivityAnaphylaxisMilk HypersensitivityEgg HypersensitivityNut Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesNut and Peanut Hypersensitivity

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

August 1, 2002

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

December 5, 2013

Record last verified: 2005-09

Locations

AU(1)