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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction?

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 Summary:

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 i
Sponsor: University Hospital, Geneva

Current Primary Outcome: 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.


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

With the aim of oral food challanges (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 activiation test in predicting the potential cross-reactivity versus oral tolerance will be assessed.


Current Secondary Outcome:

  • 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.
  • 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
  • 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.


Original Secondary Outcome:

  • 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.
  • 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
  • Follow up visits to evaluate the uprising of an allergy to a nut regulary ingested [ Time Frame: 36 months ]
    With the aim of follow up visits during a total of 36 montsh, 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 regulary consuming.


Information By: University Hospital, Geneva

Dates:
Date Received: December 3, 2012
Date Started: October 2012
Date Completion: January 2016
Last Updated: December 7, 2012
Last Verified: December 2012