Nut Allergy in Children Clinical Trial
— ProNutOfficial title:
Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction?
NCT number | NCT01744990 |
Other study ID # | CER12-020 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2012 |
Est. completion date | September 2018 |
Verified date | October 2018 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 130 |
Est. completion date | September 2018 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 16 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Infantil La Fe | Valencia | |
Switzerland | University Hospital Geneva | Geneva | GE |
United Kingdom | St. Peter's Hospital | Chertsey | Surrey |
United Kingdom | St. Thomas' Hospital | London |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva | Allergistiftung Ulrich Müller, Food Allergy Research and Education (FARE) |
Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 12 months | |
Secondary | 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 | 36 months | |
Secondary | 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. | 36 months |