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Nut Allergy Study: Double-blind Challenge and Oral Desensitization

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ClinicalTrials.gov Identifier: NCT01502878
Recruitment Status : Completed
First Posted : January 2, 2012
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Mika Juhani Mäkelä, MD, PhD, Helsinki University Central Hospital

May 27, 2011
January 2, 2012
September 13, 2016
May 2011
December 2015   (Final data collection date for primary outcome measure)
Efficacy of nut oral desensitization [ Time Frame: 7 months ]
Change from baseline in the amount of nut (mg) tolerated in a double-blind placebo-controlled oral challenge at 1 month after the 6-month oral desensitization therapy.
Same as current
Complete list of historical versions of study NCT01502878 on ClinicalTrials.gov Archive Site
  • Effect of the treatment on quality of life [ Time Frame: 7 months ]
    Change from baseline in Quality of life questionnaire square before and after the oral desensitization therapy
  • Effect of the treatment on bronchial hyperreactivity and airway inflammation [ Time Frame: 1 year ]
    Change from baseline in bronchial hyperreactivity in metacholine challenge and in eosinophilic airway inflammation measured by multiple channel exhaled nitric oxid
  • Safety of nut oral desensitization therapy [ Time Frame: 7 months ]
    Number of participants with adverse events as a measure of safety and tolerability
  • Effect of the treatment on eosinophilic airway inflammation [ Time Frame: 1 year ]
    Change from baseline in exhaled nitric oxid concentration
  • Effect of the treatment on quality of life [ Time Frame: 7 months ]
    Change from baseline in Quality of life questionnaire square before and after the oral desensitization therapy
  • Effect of the treatment on bronchial hyperreactivity and airway inflammation [ Time Frame: 1 year ]
    Change from baseline in bronchial hyperreactivity in metacholine challenge and in eosinophilic airway inflammation measured by multiple channel exhaled nitric oxid
  • Safety of nut oral desensitization therapy [ Time Frame: 7 months ]
    Number of participants with adverse events as a measure of safety and tolerablilty
  • Effect of the treatment on eosinophilic airway inflammation [ Time Frame: 1 year ]
    Change from baseline in exhaled nitric oxid concentration
Not Provided
Not Provided
 
Nut Allergy Study: Double-blind Challenge and Oral Desensitization
Nut Allergy Study: Improving Diagnosis And Treatment Of Nut Allergy
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.
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.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Nut Allergy
  • Dietary Supplement: Nut challenge
    Nut powder made from non-roasted nuts and roasted banana mixed with oats yoghurt or chocolate pudding
    Other Names:
    • Super nuts banan chips
    • Yosa oat yoghurt
    • Arla cowpower chololate pudding
  • Dietary Supplement: Nut challenge: Placebo
    Dried banana mixed with oat yoghurt or chocolate pudding
    Other Names:
    • Super nuts banan chips
    • Yosa oat yoghurt
    • Arla cowpower chololate pudding
  • Dietary Supplement: Nut oral desensitization
    Roasted peanut powder mixed with milk- and soy-free margarine
    Other Names:
    • Old Virginia Byrd Mill Fat-Light roasted peanut
    • Keiju-margarine
  • Active Comparator: Nut challenge
    Double-blind placebo controlled oral challenge 5-50-200-1000 mg peanut or hazelnut protein, or placebo administered with 30 min intervals and 2 hour-follow-up after the last dose.
    Intervention: Dietary Supplement: Nut challenge
  • Placebo Comparator: Nut challenge: Placebo
    See intervention
    Intervention: Dietary Supplement: Nut challenge: Placebo
  • Experimental: Nut oral desensitization
    Patients who have moderate to severe immediate allergic reaction at peanut challenge and who enter the oral desensitization program receive peanut protein daily, from 0,1 mg to 800 mg peanut protein, maintenance dose 800 mg.
    Intervention: Dietary Supplement: Nut oral desensitization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
200
March 2016
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • sensitization in skin prick test or in serum nut-specific IgE
  • unknown anaphylaxis suspected caused by nuts
  • never eaten nuts
  • if challenge positive with serious symptoms, OIT

Exclusion Criteria:

  • active asthma and low lung function,
  • pregnancy, cardiovascular or other disease that might worsen during the challenge and OIT
Sexes Eligible for Study: All
3 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01502878
HUCHT101060080
IAS11 ( Registry Identifier: HUCH, Skin and Allergy Hospital )
No
Not Provided
Not Provided
Mika Juhani Mäkelä, MD, PhD, Helsinki University Central Hospital
Helsinki University Central Hospital
Not Provided
Principal Investigator: Mika J Mäkelä, MD, PhD Helsinki UCH
Helsinki University Central Hospital
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP