Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction of Other Tree Nuts? (ProNut)
|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
|Condition or disease||Intervention/treatment||Phase|
|Nut Allergy in Children||Other: Oral food challenges to multiple nuts||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Interventional single arm
Single group of children undergoing the same investigations and follow up
Other: Oral food challenges to multiple nuts
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744990
|Contact: Marcel M Bergmann, MD||+41 79 55 34 firstname.lastname@example.org|
|Contact: Jean-Christoph Caubet, MD||+41 79 55 email@example.com|
|Hospital Infantil La Fe||Not yet recruiting|
|Valencia, Spain, 46009|
|Contact: Antonio Nieto, MD Nieto_ant@gva.es|
|Principal Investigator: Antonio Nieto, MD|
|University Hospital Geneva||Recruiting|
|Geneva, GE, Switzerland, 1211|
|Contact: Marcel M Bergmann, MD +41 79 55 34 787 firstname.lastname@example.org|
|Contact: Jean-Christoph Caubet, MD +41 79 55 340 85 email@example.com|
|Principal Investigator: Marcel M Bergmann, MD|
|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 firstname.lastname@example.org|
|Principal Investigator: Helen Brough, MD|
|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)|