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
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 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.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|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
- 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.
- 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
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
|University Hospital of North Norway|
|Tromsø, Norway, 9013|
|University Hospital of North Norway|
|Principal Investigator:||Claus Klingenberg, PhD||University Hospital of North Norway|