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Allergy Against Different Species of Fish in Children and Adolescents Allergic to Fish (TRO-FAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02365168
Recruitment Status : Completed
First Posted : February 18, 2015
Last Update Posted : December 15, 2015
Sponsor:
Collaborators:
University of Manchester
Helse Nord
University of Tromso
Information provided by (Responsible Party):
University Hospital of North Norway

Brief 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.

Condition or disease Intervention/treatment Phase
Fish Allergy Other: Cod_Double Blind Placebo Controlled Food Challenge Other: Salmon_Double Blind Placebo Controlled Food Challenge Other: Mackerel_Double Blind Placebo Controlled Food Challenge Other: Placebo_Double Blind Placebo Controlled Food Challenge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Allergy Against Different Species of Fish in Children and Adolescents Allergic to Fish
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Food Challenge with cod 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 Name: DBPCFC with cod

Experimental: Food Challenge with salmon 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 Name: DBPCFC with Salmon

Experimental: Food Challenge with mackerel 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 Name: DBPCFC with Mackerel

Placebo Comparator: Food Challenge with placebo Other: Placebo_Double Blind Placebo Controlled Food Challenge
DBPCFC Food Challenge with placebo covered in chocholate dessert over one day
Other Name: DBPCFC with placebo




Primary Outcome Measures :
  1. Allergic response to fish allergens with dosing escalation [ Time Frame: Within two hours after last dosage ]
    Symptoms are recorded on a clinical manifestations record sheet based on a protocol from the University Hospital of South Manchester with grading of the symptoms and defined stop criteria.


Secondary Outcome Measures :
  1. Correlation coefficient between specific IgE to fish allergens and allergic response [ Time Frame: One day after exposure ]
    Measurement of spesific IgE at baseline and allergic response up to one day after the challenge



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known or suspected allergy to fish with either positive specific s-IgE or skin prick test to one or more fish species
  • Either positive specific s-IgE or spin prick test to one or more fish species and never eaten fish.

Exclusion Criteria:

  • Serious chronic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365168


Locations
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Norway
University Hospital of North Norway
Tromsø, Norway, 9013
University Hospital of North Norway
Tromsø, Norway
Sponsors and Collaborators
University Hospital of North Norway
University of Manchester
Helse Nord
University of Tromso
Investigators
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Principal Investigator: Claus Klingenberg, PhD University Hospital of North Norway
Publications:
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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02365168    
Other Study ID Numbers: 2013/757(REK)
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Keywords provided by University Hospital of North Norway:
Fish allergy
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases