Food AllergyNCT02295267
Molecular Analysis of IgE Antibodies in Walnut Allergic Patients
A study testing walnut allergy provocation in people with Food Allergy, run by University of Zurich at 1 site in Switzerland.
Trial summary
Accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). The proposed study intends to investigate and compare the pattern of IgE antibody sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU) and central/north (C/NEU), to… Read more about this study
- Who is it for?
- Ages 1 year to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- walnut allergy provocation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to Mar 2017
- 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 1 year to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent
- Group A: positive case history of allergic reaction(s) to walnut
- Group B: positive case history of allergy to birch, grass or olive pollen and no case history of allergic reaction(s) to walnut
- Group C: no case history of atopic disease
Who cannot join
- Known pregnancy
- Breast-feeding of infant
- Treatment with the following drugs (or shortest interval between last treatment and food challenge or SPT):
- corticosteroids (2 weeks): applied systemically, to the nose or locally on the skin test area.
- antihistamines (3 days) except hydroxyzine (10 days)
- betablocker agents (1 day)
- angiotensin converting enzyme inhibitors (2 days)
- Any major organic or infectious disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Allergy Unit, Department of Dermatology, University Hospital
Zurich, 8091
About this study
Accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). The proposed study intends to investigate and compare the pattern of IgE antibody sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of novel allergen reagents.
Read the detailed description
Accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). Thus, full characterization of the major allergens of walnut and their clinical importance is an important undertaking.
The proposed study intends to investigate and compare the pattern of IgE antibody sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of novel allergen reagents.
With a view towards improved in vitro diagnostic methods, we intend to evaluate the diagnostic potential of recombinant walnut allergens in patients with walnut allergy confirmed by a positive provocation or supported by a convincing history of anaphylactic reaction(s) to walnut in the past, patients with pollinosis but no symptoms of walnut allergy and non-atopic control subjects.
- Conditions
- Food Allergy
- Being tested
- walnut allergy provocation
- Keywords
- Food allergy, Walnut, Components, Allergens
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walnut allergy provocationOther
double blind placebo controlled food challenge
| Study group | Role | What they receive |
|---|---|---|
| walnut allergy provocation | Experimental | inclusion of walnut allergic patients, food provocation with walnut Receives: Other: walnut allergy provocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of patients with walnut allergy
Measured: December 2012 to November 2017, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2012
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Paul Ehrlich Institute Langen, Hospital Clinic of Barcelona, St. Marien Hospital Bonn, Thermo Fisher Scientific, Inc
- Responsible party
- Sponsor
- Investigators
- Barbara Ballmer-Weber, PI, Principal investigator, Allergy Unit, Department of Dermatology, University Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295267
- Sponsor's protocol ID
- 2012-0519
- Status last verified
- May 2017
- First submitted
- 11 Nov 2014
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of IgE Antibodies in Walnut Allergic Patients
- ClinicalTrials.gov ID
- NCT02295267
- Acronym / sponsor ID
- 2012-0519
- Conditions
- Food Allergy
- Keywords
- Food allergy, Walnut, Components, Allergens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Paul Ehrlich Institute Langen, Hospital Clinic of Barcelona, St. Marien Hospital Bonn, Thermo Fisher Scientific, Inc
- Study start
- Dec 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 Nov 2014 (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.
Accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). The proposed study intends to investigate and compare the pattern of IgE antibody sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of novel allergen reagents.
Detailed description
Accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). Thus, full characterization of the major allergens of walnut and their clinical importance is an important undertaking.
The proposed study intends to investigate and compare the pattern of IgE antibody sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of novel allergen reagents.
With a view towards improved in vitro diagnostic methods, we intend to evaluate the diagnostic potential of recombinant walnut allergens in patients with walnut allergy confirmed by a positive provocation or supported by a convincing history of anaphylactic reaction(s) to walnut in the past, patients with pollinosis but no symptoms of walnut allergy and non-atopic control subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| walnut allergy provocation | Experimental | Other: walnut allergy provocationinclusion of walnut allergic patients, food provocation with walnut |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Group A: positive case history of allergic reaction(s) to walnut
- Group B: positive case history of allergy to birch, grass or olive pollen and no case history of allergic reaction(s) to walnut
- Group C: no case history of atopic disease
Key exclusion criteria (8 listed)
- Known pregnancy
- Breast-feeding of infant
- Treatment with the following drugs (or shortest interval between last treatment and food challenge or SPT):
- corticosteroids (2 weeks): applied systemically, to the nose or locally on the skin test area.
- antihistamines (3 days) except hydroxyzine (10 days)
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 |
|---|---|---|
| walnut allergy provocationdouble blind placebo controlled food challenge | Other | walnut allergy provocation |
Primary outcome
numbers of patients with walnut allergy
Time frame: December 2012 to November 2017, up to 5 years
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 May 2017.
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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.
Barbara Ballmer-Weber, PI principal investigator
Allergy Unit, Department of Dermatology, University Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walnut allergy provocation in people with Food Allergy, run by University of Zurich at 1 site in Switzerland.
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 8 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
numbers of patients with walnut allergy (time frame: December 2012 to November 2017, up to 5 years). 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 May 2017.