Clinical trial NCT05677074: Do Patients With Fish or Shellfish Allergy Tolerate the Consumption of Fish Oil Supplements? A Clinical Study
Official title: Tolererer Fiske- og Skaldyrsallergikere Fiskeolietilskud? Et Klinisk Studie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Hypersensitivity
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this clinical study is to test whether patients with fish or shellfish allergy can ingest different types of fish oil supplements without having an allergic reaction.

To achieve this, the recruited participants will be asked to:

* provide a blood sample (used for Basophil Histamine Release Assay)
* undergo a skin-prick-test
* partake in multiple oral provocations

These three tests will indicate the likelihood that the participants can consume fish oil supplements without adverse allergic reactions (See the detailed description for an explanation of the tests).

The investigators will test the participants tolerance for three different types fish oil supplements: Fish oil, Cod liver oil, and krill oil.

Detailed description: The Basophil Histamine Release Assay is a test that indicates whether or not the immune cells of the participant reacts when it comes into contact with the fish oils.

The skin-prick-test involves the participants having their skin exposed to the fish oils. This is done by first exposing a tiny needle to the given fish oil, and then pricking the needle into the skin on the forearm of the participant. In this way, the immune cells of the skin is exposed to the fish oils. If an allergic reaction occurs, the pricked skin will swell and turn reddish.

During the oral provocation, the participant is asked to ingest small, but increasing, doses of the fish oils over a period of 2 hours. The provocation will end when either an allergic reaction occurs or the participant has ingested a total dose of 5 mL fish oil.

Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years old)
* Legally competent
* Understands Danish

Exclusion Criteria:

* Current use of antihistamine, immunosuppressants, and/or anti-IgE-treatment that cannot be safely terminated during the study period
* The presence of severe diseases such as: Cardiovascular disease, asthma, cancer, liver disease, kidney disease, hematological diseases, neurological diseases, dementia, immunological diseases, and endocrine diseases
* Chronic urticaria
* Severe atopic eczema
* Pregnancy and/or breastfeeding
* Participation in another clinical study the previous three months
* Known excessive use of alcohol and/or substance abuse

Primary outcomes:
measure: Allergic reactions during fish oil provocation.
timeFrame: At 2 hours after the provocation or at the end of the provocation if terminated early (in case of allergic reaction).
measure: Allergic reactions during cod oil provocation.
timeFrame: At 2 hours after the provocation or at the end of the provocation if terminated early (in case of allergic reaction).
measure: Allergic reactions during krill oil provocation.
timeFrame: At 2 hours after the provocation or at the end of the provocation if terminated early (in case of allergic reaction).
Secondary outcomes:
measure: Skin-prick-test
timeFrame: 15 minutes after the skin-prick-test has been administered.
measure: Basophil Histamine Release Assay
timeFrame: At baseline
measure: Subjective allergic symptoms during oral provocations
timeFrame: At 2 hours after each provocation or at the end of the provocation if terminated early (in case of allergic reaction).
measure: Blood pressure during oral provocations
timeFrame: Change in blood pressure from baseline in case of allergic reaction
measure: Pulse during oral provocations
timeFrame: Change in blood pressure from baseline in case of allergic reaction
measure: Peak flow during oral provocations
timeFrame: Change in blood pressure from baseline in case of allergic reaction
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Gentofte Hospital
state: Hellerup
Study officials:
References: