Nut Allergy in ChildrenProNutNCT01744990
Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction of Other Tree Nuts?
A study testing Oral food challenges to multiple nuts in people with Nut Allergy in Children, run by University Hospital, Geneva at 4 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 months to 16 years
- Conditions the study is for
- Nut Allergy in Children
- What is being tested?
- Oral food challenges to multiple nuts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2012to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Uncontrolled asthma (according to the European Guidelines)(13)
- Chronic urticaria
- Children with a chronic systemic disease
- Children who are dependent on daily antihistamine use
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
St. Peter's Hospital
Chertsey, Surrey, KT16 0PZ
St. Thomas' Hospital
London, SE1 7EH
Switzerland1 site
University Hospital Geneva
Geneva, Canton of Geneva, 1211
About this study
Official title: Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction?
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
Read the 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.
- Conditions
- Nut Allergy in Children
- Being tested
- Oral food challenges to multiple nuts
- Keywords
- Nuts, allergy, Oral food challenge, skin testing, basophil activation tests, specific IgE's
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral food challenges to multiple nutsOther
| Study group | Role | What they receive |
|---|---|---|
| Interventional single arm | Other | Single group of children undergoing the same investigations and follow up Receives: Other: Oral food challenges to multiple nuts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
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
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2016
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nut Allergy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Allergistiftung Ulrich Müller, Food Allergy Research & Education
- Responsible party
- Principal investigator, Philippe Eigenmann, University Hospital, Geneva
- Investigators
- Philippe A Eigenmann, MD, Study chair, University Hospital, GenevaGideon Lack, MD, Study chair, St. Thomas' Hospital, London (UK)Antonio Nieto, MD, Study chair, Hospital Infantil La Fe, Valencia, SpainHelen Brough, MD, Principal investigator, St. Thomas' Hospital, London (UK)Haddad Diab, MD, Principal investigator, St. Peter's Hospital, Surrey (UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744990
- Sponsor's protocol ID
- CER12-020
- Acronym
- ProNut
- Status last verified
- Oct 2018
- First submitted
- 3 Dec 2012
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction?
- ClinicalTrials.gov ID
- NCT01744990
- Acronym / sponsor ID
- ProNut / CER12-020
- Conditions
- Nut Allergy in Children
- Keywords
- Nuts, allergy, Oral food challenge, skin testing, basophil activation tests, specific IgE's
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Allergistiftung Ulrich Müller, Food Allergy Research & Education
- Study start
- Oct 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional single arm | Other | Other: Oral food challenges to multiple nutsSingle group of children undergoing the same investigations and follow up |
Who may qualify
- Ages
- 12 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Uncontrolled asthma (according to the European Guidelines)(13)
- Chronic urticaria
- Children with a chronic systemic disease
- Children who are dependent on daily antihistamine use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral food challenges to multiple nuts | Other | Interventional single arm |
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.
3 secondary outcomes
Identify predictive factors of multiple nut allergy
Time frame: 12 months
Quality of life in food allergic children
Time frame: 36 months
Follow up visits to evaluate the uprising of an allergy to a nut regularly ingested
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe A Eigenmann, MD study chair
University Hospital, Geneva
Gideon Lack, MD study chair
St. Thomas' Hospital, London (UK)
Antonio Nieto, MD study chair
Hospital Infantil La Fe, Valencia, Spain
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral food challenges to multiple nuts in people with Nut Allergy in Children, run by University Hospital, Geneva at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of cross reactivity in nut allergic children (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.