NCT04239131

Brief Summary

Patients allergic to seafood and/or sensitized to Tropomyosin of Skin Prick tests SPT or crustacean origin will may be also be sensitized to edible insects. Aim of the study is to evaluate whether patients allergic to seafood and/or sensitized to Tropomyosin of SPT or crustacean origin may be more often be sensitized to edible insects used as food source.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

January 6, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

August 15, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2025

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

January 6, 2020

Last Update Submit

February 3, 2026

Conditions

Hypersensitivity, Food

Outcome Measures

Primary Outcomes (1)

  • Presence/absence of insect sensitization among seafood/Tropomyosin-sensitized patients versus patients with house dust mite sensitization alone

    Sensitization (+/-)

    1 week

Secondary Outcomes (6)

  • Sensitization pattern in insect sensitized patients in comparison between seafood-sensitized versus non-seafood-sensitized patients

    1 week

  • Sensitization pattern in seafood sensitizes patients in comparison between insect-sensitized versus non-insect-sensitized patients

    1 week

  • Sensitization pattern in insect sensitized patients in comparison between resident and immigrant populations in Switzerland

    1 week

  • Sensitization pattern in seafood sensitized patients in comparison between resident and immigrant populations in Switzerland

    1 week

  • Frequency of sensitization to the various insect allergens

    1 week

  • +1 more secondary outcomes

Study Arms (1)

All Patients

OTHER

It is a single arm study. Skin prick testing and laboratory Tests are carried out on all patients in the same way

Other: Skin prick test

Interventions

Skin prick testOTHER

a Skin prick test is planned in all patients

All Patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 \< x \< 70
  • House dust mite sensitization with or without sensitization to seafood
  • Subject is capable of giving informed consent
  • Signed informed consent

You may not qualify if:

  • Use of antihistamines, systemic corticosteroids during testing and within three days (antihistamines) or two weeks (corticosteroids) prior to testing
  • Use of immunosuppressive agents
  • History of cancer except for treated basal cell or spinal cell carcinoma of the skin
  • Active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.
  • Female patients of childbearing potential who are pregnant or breast feeding or planning a pregnancy during the duration of the trial and/or not practicing acceptable birth control for the duration of the trial
  • Known or suspected non-compliance, drug or alcohol abuse,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  • Previous enrollment into the current study,
  • Enrollment of the investigator, his/her family members, employees and other dependent persons,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergy Unit,University Hospital

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Peter Schmid, MD

    Universitätsspital Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 23, 2020

Study Start

August 15, 2021

Primary Completion

October 21, 2025

Study Completion

October 21, 2025

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)