NCT01502878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

4.6 years

First QC Date

May 27, 2011

Last Update Submit

September 12, 2016

Conditions

Nut Allergy

Keywords

Nut allergyDouble-blind placebo-controlled (DBPC) oral nut challengeNut oral immunotherapy (OIT)Nut oral desensitization

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 months

Secondary Outcomes (4)

  • Effect of the treatment on quality of life

    7 months

  • Effect of the treatment on bronchial hyperreactivity and airway inflammation

    1 year

  • Safety of nut oral desensitization therapy

    7 months

  • Effect of the treatment on eosinophilic airway inflammation

    1 year

Study Arms (3)

Nut challenge

ACTIVE COMPARATOR

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 challenge: Placebo

PLACEBO COMPARATOR

See intervention

Dietary Supplement: Nut challenge: Placebo

Nut oral desensitization

EXPERIMENTAL

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

Interventions

Nut challengeDIETARY_SUPPLEMENT

Nut powder made from non-roasted nuts and roasted banana mixed with oats yoghurt or chocolate pudding

Also known as: Super nuts banan chips, Yosa oat yoghurt, Arla cowpower chololate pudding
Nut challenge
Nut challenge: PlaceboDIETARY_SUPPLEMENT

Dried banana mixed with oat yoghurt or chocolate pudding

Also known as: Super nuts banan chips, Yosa oat yoghurt, Arla cowpower chololate pudding
Nut challenge: Placebo
Nut oral desensitizationDIETARY_SUPPLEMENT

Roasted peanut powder mixed with milk- and soy-free margarine

Also known as: Old Virginia Byrd Mill Fat-Light roasted peanut, Keiju-margarine
Nut oral desensitization

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • active asthma and low lung function,
  • pregnancy, cardiovascular or other disease that might worsen during the challenge and OIT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsinki University Central Hospital, Skin and Allergy Hospital

Helsinki, Finland, 00029, Finland

Location

Helsinki University Central Hospital, Skin and Allergy Hospital

Helsinki, Helsinki, 160, Finland

Location

Related Publications (1)

  • 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.

    PMID: 27916627DERIVED

MeSH Terms

Conditions

Nut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Mika J Mäkelä, MD, PhD

    Helsinki UCH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

May 27, 2011

First Posted

January 2, 2012

Study Start

May 1, 2011

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

FI(2)