Nut Allergy Study: Double-blind Challenge and Oral Desensitization

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

Brief 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.

Condition or disease Intervention/treatment Phase
Nut Allergy Dietary Supplement: Nut challenge Dietary Supplement: Nut challenge: Placebo Dietary Supplement: Nut oral desensitization Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nut Allergy Study: Improving Diagnosis And Treatment Of Nut Allergy
Study Start Date : May 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
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.
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

Placebo Comparator: Nut challenge: Placebo
See intervention
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

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.
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Safety of nut oral desensitization therapy [ Time Frame: 7 months ]
    Number of participants with adverse events as a measure of safety and tolerability

  4. Effect of the treatment on eosinophilic airway inflammation [ Time Frame: 1 year ]
    Change from baseline in exhaled nitric oxid concentration

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01502878

Helsinki University Central Hospital, Skin and Allergy Hospital
Helsinki, Finland, 00029
Helsinki University Central Hospital, Skin and Allergy Hospital
Helsinki, Finland, 160
Sponsors and Collaborators
Helsinki University Central Hospital
Principal Investigator: Mika J Mäkelä, MD, PhD Helsinki UCH

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mika Juhani Mäkelä, MD, PhD, Chief Physician, Helsinki University Central Hospital Identifier: NCT01502878     History of Changes
Other Study ID Numbers: HUCHT101060080
IAS11 ( Registry Identifier: HUCH, Skin and Allergy Hospital )
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by Mika Juhani Mäkelä, MD, PhD, Helsinki University Central Hospital:
Nut allergy
Double-blind placebo-controlled (DBPC) oral nut challenge
Nut oral immunotherapy (OIT)
Nut oral desensitization

Additional relevant MeSH terms:
Nut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate