Document Detail

Development of a standardized low-dose double-blind placebo-controlled challenge vehicle for the EuroPrevall project.
MedLine Citation:
PMID:  22092081     Owner:  NLM     Status:  Publisher    
To cite this article: Cochrane SA, Salt LJ, Wantling E, Rogers A, Coutts J, Ballmer-Weber BK, Fritsche P, Fernández-Rivas M, Reig I, Knulst A, Le T-M, Asero R, Beyer K, Golding M, Crevel R, Clare Mills EN, Mackie AR. Development of a standardized low-dose double-blind placebo-controlled challenge vehicle for the EuroPrevall Project. Allergy 2011; DOI: 10.1111/j.1398-9995.2011.02715.x. ABSTRACT: Background:  Double-blind placebo-controlled food challenge (DBPCFC) is the gold standard for diagnosing food allergy. Standardized materials and protocols are essential for comparing DBPCFC results for multicentre studies such as EuroPrevall. This required the development and piloting of a standardized vehicle and low-dose protocol for confirming food allergy and determination of minimum eliciting doses (MEDs). Methods:  A low-dose DBPCFC protocol was developed, with eight titrated protein doses from 3 μg to 1 g. This was delivered using a simple, microbiologically stable food base incorporating allergenic food ingredients manufactured at three sites and centrally distributed to clinical centres. Allergen blinding was assessed by a professional sensory testing panel using a triangle test. Homogeneity and allergen content were confirmed by ELISA and clinical efficacy was assessed in a pilot study, using celeriac and hazelnut as exemplars. Results:  Celeriac and hazelnut ingredients were sufficiently blinded in the dessert. The dessert meals were successfully piloted with hazelnut in allergy clinics in Spain, the Netherlands and Italy and with celeriac and hazelnut in Zurich. The challenges elicited a range of subjective and objective reactions ranging in severity from mild itching of the oral mucosa to bronchospasm. Conclusions:  A standardized challenge vehicle proven to sufficiently blind processed, powdered hazelnut and celeriac ingredients and that can be reproducibly manufactured has been developed. This pilot study shows that the vehicle is promising for the confirmation of food allergy and determination of MEDs in adults and children with body weight >28.8 kg (approximately 7-11 years old).
S A Cochrane; L J Salt; E Wantling; A Rogers; J Coutts; B K Ballmer-Weber; P Fritsche; M Fernández-Rivas; I Reig; A Knulst; T-M Le; R Asero; K Beyer; M Golding; R Crevel; E N Clare Mills; A R Mackie
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-9-19
Journal Detail:
Title:  Allergy     Volume:  -     ISSN:  1398-9995     ISO Abbreviation:  -     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-11-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7804028     Medline TA:  Allergy     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2011 John Wiley & Sons A/S.
Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire, UK Institute of Food Research, Norwich Research Park, Colney, Norwich, UK Unilever Research and Development, Colworth Science Park, Sharnbrook, Bedfordshire, UK Romer Labs UK Ltd (Formerly of Tepnel Biosystems), The Heath Business and Technical Park, Runcorn, Cheshire, UK Allergy Unit, Department of Dermatology, University Hospital Zurich, Zurich, Switzerland Allergy Department, Hospital Clinico San Carlos, Madrid, Spain University Medical Centre, Department of Dermatology/Allergology, Utrecht, the Netherlands Ambulatorio di Allergologia, Clinica San Carlo, Paderno Dugnano, Milano, Italy Department of Paediatric Pneumology and Immunology, Charité University Medical Center, Berlin, Germany Institute of Food Nutrition and Human Health (IFNHH), Massey University, Palmerston North, New Zealand.
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