NCT01728168

Brief Summary

The objective of the study is to assess the prevalence of a sensitization to proteins from legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material (lupin) in atopic and healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

November 12, 2012

Last Update Submit

February 3, 2014

Conditions

Food Allergy

Keywords

lupinpeanutsoypealegumescross-reactivitysensitizationatopy

Outcome Measures

Primary Outcomes (1)

  • Evidence of a sensitization to legume proteins

    Evidence of a sensitization to one or more legume proteins (lupin, peanut, soy, and pea)

    20 minutes after skin prick

Study Arms (2)

Atopic

Subjects with either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (\>10 points).

Non-atopic

Subjects without atopy.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female subjects. Age: 18 to 75 years. Subjects with Atopy or non-atopic subjects.

You may qualify if:

  • Male and female subjects
  • Age 18 up to 75 years
  • For group "Atopic": either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (\>10 points).

You may not qualify if:

  • Intake of antihistamines, tricyclic antidepressants, systemic corticosteroids
  • Acute allergic symptoms
  • Skin infections at the test side
  • Pregnancy, lactation
  • Acute inflammatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SRH Wald-Klinikum Gera gGmbH

Gera, Thuringia, 07548, Germany

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Martin Kaatz, Dr. med.

    SRH Wald-Klinikum Gera GmbH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. habil.

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 16, 2012

Study Start

December 1, 2012

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

DE(1)