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Nut Allergy Study: Double-blind Challenge and Oral Desensitization

NCT01502878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2016-09-13

No results posted yet for this study

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.

Conditions

  • Nut Allergy

Interventions

DIETARY_SUPPLEMENT

Nut challenge

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

DIETARY_SUPPLEMENT

Nut challenge: Placebo

Dried banana mixed with oat yoghurt or chocolate pudding

DIETARY_SUPPLEMENT

Nut oral desensitization

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

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Mika J Mäkelä, MD, PhD · Helsinki UCH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01502878 on ClinicalTrials.gov