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Nut Allergy Study: Double-blind Challenge and Oral Desensitization

Primary Purpose

Nut Allergy

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Nut challenge
Nut challenge: Placebo
Nut oral desensitization
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nut Allergy focused on measuring Nut allergy, Double-blind placebo-controlled (DBPC) oral nut challenge, Nut oral immunotherapy (OIT), Nut oral desensitization

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central Hospital, Skin and Allergy Hospital
  • Helsinki University Central Hospital, Skin and Allergy Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Nut challenge

Nut challenge: Placebo

Nut oral desensitization

Arm Description

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.

See intervention

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.

Outcomes

Primary Outcome Measures

Efficacy of nut oral desensitization
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
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
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
Number of participants with adverse events as a measure of safety and tolerability
Effect of the treatment on eosinophilic airway inflammation
Change from baseline in exhaled nitric oxid concentration

Full Information

First Posted
May 27, 2011
Last Updated
September 12, 2016
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01502878
Brief Title
Nut Allergy Study: Double-blind Challenge and Oral Desensitization
Official Title
Nut Allergy Study: Improving Diagnosis And Treatment Of Nut Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nut Allergy
Keywords
Nut allergy, Double-blind placebo-controlled (DBPC) oral nut challenge, Nut oral immunotherapy (OIT), Nut oral desensitization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nut challenge
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nut challenge: Placebo
Arm Type
Placebo Comparator
Arm Description
See intervention
Arm Title
Nut oral desensitization
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Nut challenge
Other Intervention Name(s)
Super nuts banan chips, Yosa oat yoghurt, Arla cowpower chololate pudding
Intervention Description
Nut powder made from non-roasted nuts and roasted banana mixed with oats yoghurt or chocolate pudding
Intervention Type
Dietary Supplement
Intervention Name(s)
Nut challenge: Placebo
Other Intervention Name(s)
Super nuts banan chips, Yosa oat yoghurt, Arla cowpower chololate pudding
Intervention Description
Dried banana mixed with oat yoghurt or chocolate pudding
Intervention Type
Dietary Supplement
Intervention Name(s)
Nut oral desensitization
Other Intervention Name(s)
Old Virginia Byrd Mill Fat-Light roasted peanut, Keiju-margarine
Intervention Description
Roasted peanut powder mixed with milk- and soy-free margarine
Primary Outcome Measure Information:
Title
Efficacy of nut oral desensitization
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Effect of the treatment on quality of life
Description
Change from baseline in Quality of life questionnaire square before and after the oral desensitization therapy
Time Frame
7 months
Title
Effect of the treatment on bronchial hyperreactivity and airway inflammation
Description
Change from baseline in bronchial hyperreactivity in metacholine challenge and in eosinophilic airway inflammation measured by multiple channel exhaled nitric oxid
Time Frame
1 year
Title
Safety of nut oral desensitization therapy
Description
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
7 months
Title
Effect of the treatment on eosinophilic airway inflammation
Description
Change from baseline in exhaled nitric oxid concentration
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mika J Mäkelä, MD, PhD
Organizational Affiliation
Helsinki UCH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital, Skin and Allergy Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Helsinki University Central Hospital, Skin and Allergy Hospital
City
Helsinki
ZIP/Postal Code
160
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27916627
Citation
Uotila R, Kukkonen AK, Greco D, Pelkonen AS, Makela MJ. Peanut oral immunotherapy decreases IgE to Ara h 2 and Ara h 6 but does not enhance sensitization to cross-reactive allergens. J Allergy Clin Immunol. 2017 Apr;139(4):1393-1396.e6. doi: 10.1016/j.jaci.2016.09.054. Epub 2016 Dec 1. No abstract available.
Results Reference
derived

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Nut Allergy Study: Double-blind Challenge and Oral Desensitization

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