Nut Allergy Study: Double-blind Challenge and Oral Desensitization
Condition: Nut Allergy
MeSH terms: Hypersensitivity; Nut Hypersensitivity
Study type: Interventional

Summary: 
      Nut sensitization in skin prick tests is common in areas, including Finland, where birch
      pollen is abundant. However, sensitization to nuts in skin prick test does not predict the
      possibility of allergic symptoms when nuts are ingested. In this study the investigators
      launch and perform double-blind placebo-controlled nut challenges and oral desensitization/
      protocol to those with serious symptoms in the challenge. The efficacy and safety of the new
      oral desensitization program is the primary outcome. The effect of oral desensitization on
      bronchial hyperreactivity, eosinophilic airway inflammation, and quality of life are
      secondary outcomes.
    

Detailed description: 
      The investigators aim to improve nut allergy diagnosis by launching a new double-blind
      placebo-controlled nut (peanut, hazel nut, cashew) challenge protocol. The investigators also
      launch a specific oral tolerance induction (SOTI) protocol to nuts in serious nut allergy.
      This study takes place in the Helsinki University Skin and Allergy Hospital between May 2011
      and December 2015. Inclusion criteria: age 6 to 18 years and suspected nut allergy (unclear
      anaphylaxis possibly caused by nuts, skin prick test to nuts ≥ 10 mm or specific-IgE ≥ 20
      kU/L and have never eaten nuts, or avoids nuts and does not dare try nuts at home). Patients
      having uncontrolled asthma or other lung disease, having cardiovascular disease or other
      systemic disease, using beta-blockers, and having poor compliance, are excluded. Methods:The
      investigators perform skin prick tests to peanut, tree nuts and seeds, take a blood sample
      before the double-blind placebo-controlled food challenges (DBPCFC), and measure total IgE
      and specific-IgE to birch, peanut, hazel nut, allergen components Ara h 1, 2, 3, and 8, and
      Cor a 1 and 8. Then the serum samples are kept frozen for further component and immunologic
      analyses. The investigators put iv before the challenge. In DBPCFC the patients receive 5 mg,
      50 mg, 200mg, and 1000mg nut protein mixt with placebo, or placebo every 30 minutes. The
      severity of the allergic reaction is estimated using a modified severity scale. The
      probability of severe/moderate reaction at low (<0.7 kU/L) and at increased (>0.7 kU/L) Ara h
      2 and 8 concentrations is the primary end-point in the DBPCFC. The investigators also
      correlate the concentrations of Ara h 2 with the severity score. Patients with moderate or
      severe reaction in the challenge will be offered desensitization therapy "SOTI" using(pea)nut
      flour mixed with milk-free margarine. The first dose of 0.1 mg nut protein is given at
      hospital part of the up-dosing is made at home every 2 weeks. The patient takes an
      antihistamine 1 hour before each daily dose. An epinephrine autoinjector and prednisolone
      tablets are also prescribed for emergency use. The desensitization protocol takes 28 weeks
      and is personalized when needed. Exercise is avoided 1 hour following each dose. Before and
      after the SOTI the investigators measure food related quality of life using standardized
      questionnaires, and perform metacholine challenge and measure exhaled nitric oxid. After the
      SOTI the investigators take blood samples and perform DBPCFC again.
    

Intervention name(s): Nut challenge; Nut challenge: Placebo; Nut oral desensitization
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Nut powder made from non-roasted nuts and roasted banana mixed with oats yoghurt or chocolate pudding; Dried banana mixed with oat yoghurt or chocolate pudding; Roasted peanut powder mixed with milk- and soy-free margarine
Other intervention name(s): Super nuts banan chips; Yosa oat yoghurt; Arla cowpower chololate pudding; Super nuts banan chips; Yosa oat yoghurt; Arla cowpower chololate pudding; Old Virginia Byrd Mill Fat-Light roasted peanut; Keiju-margarine
Intervention MeSH terms: Cefpodoxime; Cefpodoxime proxetil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Nut allergy; Double-blind placebo-controlled (DBPC) oral nut challenge; Nut oral immunotherapy (OIT); Nut oral desensitization