Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction of Other Tree Nuts?

NCT01744990 | Completed

• 1 other identifier: CER12-020
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 4

Brief Summary

The aim of this study is to identify, based on standardized food provocation tests, which nuts allergic patients need a selective, or a complete dietary eviction of all kind of nuts (nuts being defined as peanut, all tree nuts, pine nut and sesame). The investigators postulate that predictive factors of multiple nut allergy are high specific immunoglobulin E level, positive skin tests and/or clinical markers, such as atopic dermatitis, presence of other food allergies or a history of a severe previous reaction

Conditions

Nut Allergy in Children

Keywords

Nuts; allergy; Oral food challenge; skin testing; basophil activation tests; specific IgE's

Outcome Measures

Primary Outcomes (1)

• Evaluation of cross reactivity in nut allergic children

  With the aim of oral food challenges (OFC's)in nut allergic children, we want to study the allergic cross-reactivity of all nut. The efficiency of various allergological testing, like skin prick tests, specific IgE or basophil activation test in predicting the potential cross-reactivity versus oral tolerance will be assessed.

  12 months

Secondary Outcomes (3)

• Identify predictive factors of multiple nut allergy

  12 months

• Quality of life in food allergic children

  36 months

• Follow up visits to evaluate the uprising of an allergy to a nut regularly ingested

  36 months

Study Arms (1)

Interventional single arm

OTHER

Single group of children undergoing the same investigations and follow up

Other: Oral food challenges to multiple nuts

Interventions

Oral food challenges to multiple nuts OTHER

Interventional single arm

Eligibility Criteria

• Age: 12 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with convincing history of IgE-mediated systemic allergic reaction (not only oral symptoms) after consumption of one or more "nuts" (peanut, hazelnut, walnut, almond, cashew, pecan, Brazil, macadamia, pine nut, sesame) within last 12 months and SPT \> 3 mm and/or positive specific IgE (\>0.1 kU/l).
• Children without a convincing history of IgE-mediated systemic allergic reaction (for example only oral symptoms) after consumption of one or more "nuts" (peanut, hazelnut, walnut, almond, cashew, pecan, brazil, macadamia, pistachio, pine nut, sesame) but with clear evidence of sensitization (SPT \> 3 mm and/or positive specific IgE (\> 0.1 kU/l) and a positive standardized food challenge to the nut.
• Informed consent approved and signed by the patient's legal representative and, if applicable, by the child itself.

You may not qualify if:

• Uncontrolled asthma (according to the European Guidelines)(13)
• Chronic urticaria
• Children with a chronic systemic disease
• Children who are dependent on daily antihistamine use

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Allergistiftung Ulrich Müller: collaborator
• Food Allergy Research & Education: collaborator

Study Sites (4)

Hospital Infantil La Fe

Valencia, 46009, Spain

Location

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

St. Peter's Hospital

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

St. Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Philippe A Eigenmann, MD

  University Hospital, Geneva

  STUDY CHAIR

• Gideon Lack, MD

  St. Thomas' Hospital, London (UK)

  STUDY CHAIR

• Antonio Nieto, MD

  Hospital Infantil La Fe, Valencia, Spain

  STUDY CHAIR

• Helen Brough, MD

  St. Thomas' Hospital, London (UK)

  PRINCIPAL INVESTIGATOR

• Haddad Diab, MD

  St. Peter's Hospital, Surrey (UK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Pediatric Allergy Unit, Department of Pediatrics

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 7, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: September 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

ES (1); CH (1); GB (2)