Allergy Against Different Species of Fish in Children and Adolescents Allergic to Fish

Summary

Study hypothesis:

Some children and adolescents with fish allergy can tolerate eating some species of fish

Purpose of the study:

The purpose of this study is to determine to which degree fish allergic children and adolescents can tolerate some species of fish and find the minimal eliciting allergen dose to which only 10% of participants get allergic reaction.

Participants:

Participants are 40 patients recruited from children and adolescents outpatient clinics at the University Hospital of North Norway with a history of fish allergy and sensibilisation of one or more fish species with either positive specific IgE in serum or skin prick test. Patients with sensibilisation to one or more fish species that never have eaten fish are also recruited.

Method:

* All participants undergo a clinical examination including lung function test with spirometry before inclusion in the study.
* All participants are tested for allergic sensibilisation with measure of specific IgE against common food and inhalation allergens in addition to 10 different fish species.
* All participants are challenged with cod, salmon, mackerel and placebo, disguised in a chocolate mousse. The challenges are performed in randomized order with Double Blind Placebo Controlled Food Challenge (DBPCFC) on 4 different challenge days with minimum 6 weeks in between each challenge day.
* Participant with allergy to pollen will not be challenged during pollen season.
* Test food is developed especially to this study in cooperation with The National Institute of Food Research in Norway and The University of Manchester. The National Institute of Food Research in Norway have produced a dried powder of cod, salmon and mackerel. The "Molecular Allergology group at Manchester Institute of Biotechnology, the University of Manchester, have produced test kits based on chocolate mousse containing low and high doses of the fish powders. The National Institute of Food Research have measured protein content and microbiology in the fish powders. The Molecular Allergology group have provided quality measurements of the final product and tested the disguise in a sensoric test panel.
* Participants with no allergic reaction to one or more of the blinded challenges undergo open food challenge with larger doses of cooked fish than used in the DBPCFC, after the randomization has been broken.

Conditions

• Fish Allergy

Interventions

OTHER

Cod_Double Blind Placebo Controlled Food Challenge

DBPCFC Food Challenge with cod in the following doses: 3µg, 600µg, 12 mg, 120 mg, and 1g covered in chocholate dessert over one day

OTHER

Salmon_Double Blind Placebo Controlled Food Challenge

DBPCFC Food Challenge with salmon in the following doses: 3µg, 600µg, 12 mg, 120 mg, and 1g covered in chocholate dessert over one day

OTHER

Mackerel_Double Blind Placebo Controlled Food Challenge

DBPCFC Food Challenge with mackerel in the following doses: 3µg, 600µg, 12 mg, 120 mg, and 1g covered in chocholate dessert over one day

OTHER

Placebo_Double Blind Placebo Controlled Food Challenge

DBPCFC Food Challenge with placebo covered in chocholate dessert over one day

Sponsors & Collaborators

• University of Manchester

  collaborator OTHER

• Helse Nord

  collaborator INDUSTRY

• University of Tromso

  collaborator OTHER

• University Hospital of North Norway

  lead OTHER

Principal Investigators

• Claus Klingenberg, PhD · University Hospital of North Norway

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

5 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2015-09-30

Completion

2015-09-30

Countries

• Norway

Study Locations