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

NCT02365168 | Completed

• 1 other identifier: 2013/757(REK)
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Fish Allergy

Keywords

Fish allergy

Outcome Measures

Primary Outcomes (1)

• Allergic response to fish allergens with dosing escalation

  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.

  Within two hours after last dosage

Secondary Outcomes (1)

• Correlation coefficient between specific IgE to fish allergens and allergic response

  One day after exposure

Study Arms (4)

Food Challenge with cod

EXPERIMENTAL

Other: Cod_Double Blind Placebo Controlled Food Challenge

Food Challenge with salmon

EXPERIMENTAL

Other: Salmon_Double Blind Placebo Controlled Food Challenge

Food Challenge with mackerel

EXPERIMENTAL

Other: Mackerel_Double Blind Placebo Controlled Food Challenge

Food Challenge with placebo

PLACEBO COMPARATOR

Other: Placebo_Double Blind Placebo Controlled Food Challenge

Interventions

Cod_Double Blind Placebo Controlled Food Challenge OTHER

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

Also known as: DBPCFC with cod

Food Challenge with cod

Salmon_Double Blind Placebo Controlled Food Challenge OTHER

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

Also known as: DBPCFC with Salmon

Food Challenge with salmon

Mackerel_Double Blind Placebo Controlled Food Challenge OTHER

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

Also known as: DBPCFC with Mackerel

Food Challenge with mackerel

Placebo_Double Blind Placebo Controlled Food Challenge OTHER

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

Also known as: DBPCFC with placebo

Food Challenge with placebo

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Serious chronic disease

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Manchester: collaborator
• Helse Nord: collaborator
• University of Tromso: collaborator

Study Sites (2)

University Hospital of North Norway

Tromsø, 9013, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

Related Publications (2)

• Lopata AL, Lehrer SB. New insights into seafood allergy. Curr Opin Allergy Clin Immunol. 2009 Jun;9(3):270-7. doi: 10.1097/ACI.0b013e32832b3e6f.

  PMID: 19398906 BACKGROUND

• Tsabouri S, Triga M, Makris M, Kalogeromitros D, Church MK, Priftis KN. Fish and shellfish allergy in children: review of a persistent food allergy. Pediatr Allergy Immunol. 2012 Nov;23(7):608-15. doi: 10.1111/j.1399-3038.2012.01275.x. Epub 2012 May 3.

  PMID: 22554093 BACKGROUND

MeSH Terms

Interventions

CVD protocol

Study Officials

• Claus Klingenberg, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: February 18, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

NO (2)