Prospective Study About Sensitization Pattern to Insects... | NCT04239131

Studies
Prospective Study About Sensitization Pattern to Insects as Food Source in Patients With House Dust Mite Allergy

NCT04239131

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Feb 5, 2026Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Hypersensitivity, Food

Interventions

Skin prick test

Countries

Switzerland

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

Status Module

Record Verification Date

Feb 2026

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 15, 2021Actual

Primary Completion Date

Oct 21, 2025Actual

Completion Date

Oct 21, 2025Actual

First Submitted Date

Jan 6, 2020

First Submission Date that Met QC Criteria

Jan 20, 2020

First Posted Date

Jan 23, 2020Actual

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

Feb 3, 2026

Last Update Posted Date

Feb 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

House dust mite allergy is a common problem in Europe. In addition to inhalant allergies sensitization to mites can be related to food allergy namely seafood. Insects are also widespread food sources in many regions of the world.

In this study skin testing and laboratory tests are planned in patients with known house dust mite allergy to evaluate a possible sensitization to insects. Patients must also complete a questionnaire. A drug therapy or other intervention is not planned.

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.

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

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Skin prick test	Other	a Skin prick test is planned in all patients	All Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence/absence of insect sensitization among seafood/Tropomyosin-sensitized patients versus patients with house dust mite sensitization alone	Sensitization (+/-)	1 week

Secondary Outcomes

Measure	Description	Time Frame
Sensitization pattern in insect sensitized patients in comparison between seafood-sensitized versus non-seafood-sensitized patients	Sensitization (+/-)	1 week
Sensitization pattern in seafood sensitizes patients in comparison between insect-sensitized versus non-insect-sensitized patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Peter Schmid, MD	Universitätsspital Zürich	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Allergy Unit,University Hospital		Zurich	Canton of Zurich	8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005512	Food Hypersensitivity

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D010328	Patch Tests

Ancestor Terms

ID	Term
D012882	Skin Tests
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided