Nut Allergy Study: Double-blind Challenge and Oral Desensitization

This study is currently recruiting participants.
Verified January 2014 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Mika Juhani Mäkelä, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01502878
First received: May 27, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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 Intervention
Nut Allergy
Dietary Supplement: Nut challenge
Dietary Supplement: Nut challenge: Placebo
Dietary Supplement: Nut oral desensitization

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Nut Allergy Study: Improving Diagnosis And Treatment Of Nut Allergy

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Efficacy of nut oral desensitization [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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:
  • Effect of the treatment on quality of life [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Change from baseline in exhaled nitric oxid concentration


Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502878

Contacts
Contact: Mika J Mäkelä, MD, PhD +35850 ext 5527421 mika.makela@hus.fi
Contact: Anna Kaarina Kukkonen, MD, PhD kaarina.kukkonen@hus.fi

Locations
Finland
Helsinki University Central Hospital, Skin and Allergy Hospital Recruiting
Helsinki, Finland, 00029
Contact: Mikä J Mäkelä, MD, PhD    +38594711    mika.makela@hus.fi   
Contact: Anna Kaarina Kukkonen, MD, PhD    +35894711    kaarina.kukkonen@hus.fi   
Helsinki University Central Hospital, Skin and Allergy Hospital Recruiting
Helsinki, Finland, 160
Contact: Anna Kaarina Kukkonen, MD, Ph D    +35894711    kaarina.kukkonen@hus.fi   
Contact: Anna S Pelkonen, MD, PhD    +35894711    anna.pelkonen@hus.fi   
Sub-Investigator: Anna Kaarina Kukkonen, MD, PhD         
Principal Investigator: Mika Mäkelä, MD, PhD         
Sub-Investigator: Anna S Pelkonen, MD, PhD         
Sub-Investigator: Mikael O Kuitunen, MD, PhD         
Sub-Investigator: Helena Voutilainen, M.Sc.         
Sub-Investigator: Malmberg Pekka, MD, PhD         
Sub-Investigator: Soili Mäkinen-Kiljunen, PhD         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Mika J Mäkelä, MD, PhD Helsinki UCH
  More Information

No publications provided

Responsible Party: Mika Juhani Mäkelä, MD, PhD, Chief Physician, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01502878     History of Changes
Other Study ID Numbers: HUCHT101060080, IAS11
Study First Received: May 27, 2011
Last Updated: January 8, 2014
Health Authority: Finland: Ethics Committee
Finland: Ministry of Social Affairs and Health

Keywords provided by 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:
Hypersensitivity
Nut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on April 17, 2014