NCT02295267

Brief Summary

Accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). The proposed study intends to investigate and compare the pattern of IgE antibody sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of novel allergen reagents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

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

December 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

4.1 years

First QC Date

November 11, 2014

Last Update Submit

May 10, 2017

Conditions

Food Allergy

Keywords

Food allergyWalnutComponentsAllergens

Outcome Measures

Primary Outcomes (1)

  • numbers of patients with walnut allergy

    December 2012 to November 2017, up to 5 years

Study Arms (1)

walnut allergy provocation

EXPERIMENTAL

inclusion of walnut allergic patients, food provocation with walnut

Other: walnut allergy provocation

Interventions

walnut allergy provocationOTHER

double blind placebo controlled food challenge

walnut allergy provocation

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Group A: positive case history of allergic reaction(s) to walnut
  • Group B: positive case history of allergy to birch, grass or olive pollen and no case history of allergic reaction(s) to walnut
  • Group C: no case history of atopic disease

You may not qualify if:

  • Known pregnancy
  • Breast-feeding of infant
  • Treatment with the following drugs (or shortest interval between last treatment and food challenge or SPT):
  • corticosteroids (2 weeks): applied systemically, to the nose or locally on the skin test area.
  • antihistamines (3 days) except hydroxyzine (10 days)
  • betablocker agents (1 day)
  • angiotensin converting enzyme inhibitors (2 days)
  • Any major organic or infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergy Unit, Department of Dermatology, University Hospital

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Barbara Ballmer-Weber, PI

    Allergy Unit, Department of Dermatology, University Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2014

First Posted

November 20, 2014

Study Start

December 1, 2012

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

CH(1)