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

Primary Purpose

Nut Allergy in Children

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Oral food challenges to multiple nuts
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nut Allergy in Children focused on measuring Nuts, allergy, Oral food challenge, skin testing, basophil activation tests, specific IgE's

Eligibility Criteria

12 Months - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Infantil La Fe
  • University Hospital Geneva
  • St. Peter's Hospital
  • St. Thomas' Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Interventional single arm

Arm Description

Single group of children undergoing the same investigations and follow up

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Identify predictive factors of multiple nut allergy
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.
Quality of life in food allergic children
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
Follow up visits to evaluate the uprising of an allergy to a nut regularly ingested
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.

Full Information

First Posted
December 3, 2012
Last Updated
October 9, 2018
Sponsor
University Hospital, Geneva
Collaborators
Allergistiftung Ulrich Müller, Food Allergy Research & Education
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1. Study Identification

Unique Protocol Identification Number
NCT01744990
Brief Title
Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction of Other Tree Nuts?
Acronym
ProNut
Official Title
Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
Allergistiftung Ulrich Müller, Food Allergy Research & Education

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nut Allergy in Children
Keywords
Nuts, allergy, Oral food challenge, skin testing, basophil activation tests, specific IgE's

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional single arm
Arm Type
Other
Arm Description
Single group of children undergoing the same investigations and follow up
Intervention Type
Other
Intervention Name(s)
Oral food challenges to multiple nuts
Primary Outcome Measure Information:
Title
Evaluation of cross reactivity in nut allergic children
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Identify predictive factors of multiple nut allergy
Description
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.
Time Frame
12 months
Title
Quality of life in food allergic children
Description
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
Time Frame
36 months
Title
Follow up visits to evaluate the uprising of an allergy to a nut regularly ingested
Description
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.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe A Eigenmann, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gideon Lack, MD
Organizational Affiliation
St. Thomas' Hospital, London (UK)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antonio Nieto, MD
Organizational Affiliation
Hospital Infantil La Fe, Valencia, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helen Brough, MD
Organizational Affiliation
St. Thomas' Hospital, London (UK)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haddad Diab, MD
Organizational Affiliation
St. Peter's Hospital, Surrey (UK)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Infantil La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
University Hospital Geneva
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
St. Peter's Hospital
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

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

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