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

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ClinicalTrials.gov Identifier: NCT01744990
Recruitment Status : Unknown
Verified December 2012 by Dr. Marcel Bergmann, University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : December 7, 2012
Last Update Posted : December 10, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Nut Allergy in Children Other: Oral food challenges to multiple nuts

Detailed Description:

Food allergy in children is a disease of growing importance, current estimation in school age children are between 4 and 8 %. The most frequently involved foods in IgE reaction in school-aged children are hazelnut (especially in Switzerland according to the ongoing Swiss Registry, Wiesner et al, personal communication) and peanut. Tree nuts and peanut allergies are often involved in severe reactions, including cases of death by anaphylaxis. In addition, the disease is long-lasting as Fleischer et al could show that only 9% of children with nut allergies will outgrew from it. This number is worse than for peanut where a positive outcome is seen in 20% of the patients.

Food challenges are the most reliable tests to investigate a possible food allergy, but these are time consuming and may elicit severe reactions in patients with a previous history of anaphylactic reactions(8). There are no allergy tests able at this time to predict with certainty the clinical reactivity, although Sampson et al could identify a general tree nuts specific IgE cut-off level with a high positive predictive value for clinical reactivity.

It could be demonstrated, in well-designed studies, that in vitro cross-sensitivity between tree nuts (members of the oleaginous family) and peanut (members of the legume family) is frequent (86%). However, clinical reactions to tree nuts are estimated to be present in only 40% of peanut allergic patients. Therefore 60% of peanut allergic patients may eat tree nuts without reactions.

Similarly, there is a large in vitro cross-sensitivity between tree nuts. However, it is not known to date if this cross-sensitivity relates to clinical reactivity. Consequently, in case of one tree nut allergy, strict eviction to all nuts is largely recommended, and possibly results in a unnecessary dietary eviction of all tree nuts leading to a high impact on the quality of life of the children.

We aim 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). We 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction?
Study Start Date : October 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Interventional single arm
Single group of children undergoing the same investigations and follow up
Other: Oral food challenges to multiple nuts


Outcome Measures

Primary Outcome Measures :
  1. Evaluation of cross reactivity in nut allergic children [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Identify predictive factors of multiple nut allergy [ Time Frame: 12 months ]
    We postulate that predictive factors of multiple nut allergy are high specific IgE 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.

  2. Quality of life in food allergic children [ Time Frame: 36 months ]
    Studying variation of quality of life after reintroduction of various nuts with a validated food allergy of life questionnaire (FAQLQ). filled up by the parents and/or the child during follow uip visits

  3. Follow up visits to evaluate the uprising of an allergy to a nut regularly ingested [ Time Frame: 36 months ]
    With the aim of follow up visits during a total of 36 months, will want to evaluate the consumption of tolerated or reintroduced nuts. The goal is to analyze the risk an nut allergic child might present a new allergy to an other nut he is regularly consuming.


Eligibility Criteria

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Ages Eligible for Study:   12 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 1 - 16 years of age at the time of inclusion (a minimum of 75 children < 6 years old required, over the 3 centers)
  • 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.

Exclusion Criteria:

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744990


Contacts
Contact: Marcel M Bergmann, MD +41 79 55 34 787 marcel.bergmann@hcuge.ch
Contact: Jean-Christoph Caubet, MD +41 79 55 4085 jeanchristoph.caubet@hcuge.ch

Locations
Spain
Hospital Infantil La Fe Not yet recruiting
Valencia, Spain, 46009
Contact: Antonio Nieto, MD       Nieto_ant@gva.es   
Principal Investigator: Antonio Nieto, MD         
Switzerland
University Hospital Geneva Recruiting
Geneva, GE, Switzerland, 1211
Contact: Marcel M Bergmann, MD    +41 79 55 34 787    marcel.bergmann@hcuge.ch   
Contact: Jean-Christoph Caubet, MD    +41 79 55 340 85    jean-christoph.caubet@hcuge.ch   
Principal Investigator: Marcel M Bergmann, MD         
United Kingdom
St. Peter's Hospital Not yet recruiting
Chertsey, Surrey, United Kingdom, KT16 0PZ
Contact: Haddad Diab, MD    +44 (0)1932 692038    Diab.Haddad@asph.nhs.uk   
Principal Investigator: Haddad Diab, MD         
St. Thomas' Hospital Not yet recruiting
London, United Kingdom, SE1 7EH
Contact: Helen Brough, MD    +44 (0)2071889783    hbrough@doctors.org.uk   
Principal Investigator: Helen Brough, MD         
Sponsors and Collaborators
University Hospital, Geneva
Allergistiftung Ulrich Müller
Investigators
Study Chair: 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
Principal Investigator: Helen Brough, MD St. Thomas' Hospital, London (UK)
Principal Investigator: Haddad Diab, MD St. Peter's Hospital, Surrey (UK)
More Information

Responsible Party: Dr. Marcel Bergmann, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01744990     History of Changes
Other Study ID Numbers: CER12-020
First Posted: December 7, 2012    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by Dr. Marcel Bergmann, University Hospital, Geneva:
Nuts
allergy
Oral food challenge
skin testing
basophil activation tests
specific IgE's

Additional relevant MeSH terms:
Hypersensitivity
Nut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate