Food AllergyiFAAMNCT02295397
Integrated Approaches to Food Allergen and Allergy Risk Management
A study testing food in people with Food Allergy, run by University of Zurich at 1 site in Switzerland.
Trial summary
Patients with history of a food allergy to hazelnut, walnut or celeriac will undergo food provocation with a dose of the allergenic food to which 5% of the respective food allergic population (ED05) has been calculated to respond with allergic reactions (single shot study). Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Feb 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent
- For single shot study: history of a hazelnut, walnut, celeriac allergy due to an unequivocal accidental exposure with typical acute allergic reaction within the preceding 2 years and positive allergen-specific skin prick test/specific Immunoglobulin E or recent positive oral food challenge with hazel, walnut or celeriac within previous 2 years in children <16 years, but no time limit specified for adults
- For matrix comparison study: history of peanut or hazelnut allergy
- For walnut/PPI study: history of walnut allergy. The minimum age for this study is 18 years
Who cannot join
- Severe disease (heart, liver, kidney), acute febrile infection
- Intake of Ketotifen (past 2 weeks), corticosteroids (past 2 weeks), histamine-1-receptor blocker (past 3 days apart first generation past 7 days)
- Anaphylactic reaction (past 4 weeks)
- Uncontrolled bronchial asthma, forced expiratory volume < 70% predicted
- Pregnancy
- Acute infection or allergy
Show all 10Show fewer
- Uncontrolled atopic dermatitis
- Chronic urticaria
- Mastocytosis
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Allergy Unit, Department of Dermatology, University Hospital
Zurich, 8091
About this study
Patients with history of a food allergy to hazelnut, walnut or celeriac will undergo food provocation with a dose of the allergenic food to which 5% of the respective food allergic population (ED05) has been calculated to respond with allergic reactions (single shot study).
In patients with a hazelnut or peanut allergy a double-blind placebo controlled food challenge with cookies containing either placebo or hazelnut and peanut respectively will be performed to determine threshold levels eliciting an allergic reaction. The results for threshold levels determined by cookie matrix will be compared to the results gained from the EuroPrevall project (matrix comparison study).
In patients with a walnut allergy double-blind placebo controlled provocation with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on the threshold level and on the clinical manifestation.
Read the detailed description
single shot study, matrix comparison and walnut/PPI study
- detailed case history, blood sampling and prick testing with different foods will performed.
- food provocation with a chocolate dessert meal containing either hazelnut, walnut or celeriac (ED05) will be performed (single shot study) in patients with a positive case history of an allergic reaction to either hazelnut, walnut or celeriac or with two meals containing either placebo or hazelnut and peanut respectively in hazelnut and peanut allergic patients or with three meals containing either placebo or walnut in walnut allergic patients.
- in patients with a negative single shot challenge an open provocation with native hazelnut, walnut, celeriac will be performed unless the patients do not have had a positive previous food provocation with the respective food. In patients with a negative double-blind placebo-controlled food challenge an open provocation with hazelnut or peanut or walnut will be performed to confirm tolerance.
- Conditions
- Food Allergy
- Being tested
- food
- Keywords
- Food provocation, Matrix effect, ED05, Allergy, Proton Pump Inhibitor
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foodOther
food provocation, skin testing, blood sampling
| Study group | Role | What they receive |
|---|---|---|
| food provocation | Experimental | open and placebo-controlled food challenges Receives: Other: food |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of patients reacting to ED05 in hazelnut, walnut, celeriac allergy
Measured: November 2014 to February 2017, up to 27 months
Secondary outcomes (2)
numbers of patients reacting to a defined dose of peanut and hazelnut in titrated challenges
Measured: November 2014 to February 2017, up to 27 months
Change in the threshold dose of walnut that induces an allergic reaction after the intake of therapeutic doses of omeprazole Change in the severity of walnut allergy after the intake of therapeutic doses of omeprazole
Measured: February 2015 to February 2017, up to 27 months
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 startNov 2014
- Primary completionFeb 2017
- Study completionFeb 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Cork University Hospital, Charite University, Berlin, Germany, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Nebraska Lincoln, Region Hovedstadens Apotek, Servicio Madrileño de Salud, Madrid, Spain, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
- Investigators
- Clare Mills, Coordinator, Study chair, University Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295397
- Sponsor's protocol ID
- iFAAM
- Acronym
- iFAAM
- 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
- Integrated Approaches to Food Allergen and Allergy Risk Management
- ClinicalTrials.gov ID
- NCT02295397
- Acronym / sponsor ID
- iFAAM / iFAAM
- Conditions
- Food Allergy
- Keywords
- Food provocation, Matrix effect, ED05, Allergy, Proton Pump Inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Cork University Hospital, Charite University, Berlin, Germany, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Nebraska Lincoln, Region Hovedstadens Apotek, Servicio Madrileño de Salud, Madrid, Spain, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- Nov 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 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.
Patients with history of a food allergy to hazelnut, walnut or celeriac will undergo food provocation with a dose of the allergenic food to which 5% of the respective food allergic population (ED05) has been calculated to respond with allergic reactions (single shot study).
In patients with a hazelnut or peanut allergy a double-blind placebo controlled food challenge with cookies containing either placebo or hazelnut and peanut respectively will be performed to determine threshold levels eliciting an allergic reaction. The results for threshold levels determined by cookie matrix will be compared to the results gained from the EuroPrevall project (matrix comparison study).
In patients with a walnut allergy double-blind placebo controlled provocation with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on the threshold level and on the clinical manifestation.
Detailed description
single shot study, matrix comparison and walnut/PPI study
- detailed case history, blood sampling and prick testing with different foods will performed.
- food provocation with a chocolate dessert meal containing either hazelnut, walnut or celeriac (ED05) will be performed (single shot study) in patients with a positive case history of an allergic reaction to either hazelnut, walnut or celeriac or with two meals containing either placebo or hazelnut and peanut respectively in hazelnut and peanut allergic patients or with three meals containing either placebo or walnut in walnut allergic patients.
- in patients with a negative single shot challenge an open provocation with native hazelnut, walnut, celeriac will be performed unless the patients do not have had a positive previous food provocation with the respective food. In patients with a negative double-blind placebo-controlled food challenge an open provocation with hazelnut or peanut or walnut will be performed to confirm tolerance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| food provocation | Experimental | Other: foodopen and placebo-controlled food challenges |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- For single shot study: history of a hazelnut, walnut, celeriac allergy due to an unequivocal accidental exposure with typical acute allergic reaction within the preceding 2 years and positive allergen-specific skin prick test/specific Immunoglobulin E or recent positive oral food challenge with hazel, walnut or celeriac within previous 2 years in children <16 years, but no time limit specified for adults
- For matrix comparison study: history of peanut or hazelnut allergy
- For walnut/PPI study: history of walnut allergy. The minimum age for this study is 18 years
Key exclusion criteria (10 listed)
- Severe disease (heart, liver, kidney), acute febrile infection
- Intake of Ketotifen (past 2 weeks), corticosteroids (past 2 weeks), histamine-1-receptor blocker (past 3 days apart first generation past 7 days)
- Anaphylactic reaction (past 4 weeks)
- Uncontrolled bronchial asthma, forced expiratory volume < 70% predicted
- Pregnancy
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 |
|---|---|---|
| foodfood provocation, skin testing, blood sampling | Other | food provocation |
Primary outcome
numbers of patients reacting to ED05 in hazelnut, walnut, celeriac allergy
Time frame: November 2014 to February 2017, up to 27 months
2 secondary outcomes
numbers of patients reacting to a defined dose of peanut and hazelnut in titrated challenges
Time frame: November 2014 to February 2017, up to 27 months
Change in the threshold dose of walnut that induces an allergic reaction after the intake of therapeutic doses of omeprazole Change in the severity of walnut allergy after the intake of therapeutic doses of omeprazole
Time frame: February 2015 to February 2017, up to 27 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 May 2017.
Related trials for Food Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
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.
Clare Mills, Coordinator study chair
University Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food 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 10 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 reacting to ED05 in hazelnut, walnut, celeriac allergy (time frame: November 2014 to February 2017, up to 27 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 May 2017.