Nut AllergyNCT01502878
Nut Allergy Study: Double-blind Challenge and Oral Desensitization
A study testing Nut challenge and Nut oral desensitization in people with Nut Allergy, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
Nut sensitization in skin prick tests is common in areas, including Finland, where birch pollen is abundant. However, sensitization to nuts in skin prick test does not predict the possibility of allergic symptoms when nuts are ingested. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Nut Allergy
- What is being tested?
- Nut challenge and Nut oral desensitization
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesFinland
- Study dates
- May 2011to Mar 2016
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- sensitization in skin prick test or in serum nut-specific IgE
- unknown anaphylaxis suspected caused by nuts
- never eaten nuts
- if challenge positive with serious symptoms, OIT
Who cannot join
- active asthma and low lung function,
- pregnancy, cardiovascular or other disease that might worsen during the challenge and OIT
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central Hospital, Skin and Allergy Hospital
Helsinki, Finland, 00029
Helsinki University Central Hospital, Skin and Allergy Hospital
Helsinki, Helsinki, 160
About this study
Official title: Nut Allergy Study: Improving Diagnosis And Treatment Of Nut Allergy
Nut sensitization in skin prick tests is common in areas, including Finland, where birch pollen is abundant. However, sensitization to nuts in skin prick test does not predict the possibility of allergic symptoms when nuts are ingested. In this study the investigators launch and perform double-blind placebo-controlled nut challenges and oral desensitization/ protocol to those with serious symptoms in the challenge. The efficacy and safety of the new oral desensitization program is the primary outcome. The effect of oral desensitization on bronchial hyperreactivity, eosinophilic airway inflammation, and quality of life are secondary outcomes.
Read the detailed description
The investigators aim to improve nut allergy diagnosis by launching a new double-blind placebo-controlled nut (peanut, hazel nut, cashew) challenge protocol. The investigators also launch a specific oral tolerance induction (SOTI) protocol to nuts in serious nut allergy. This study takes place in the Helsinki University Skin and Allergy Hospital between May 2011 and December 2015. Inclusion criteria: age 6 to 18 years and suspected nut allergy (unclear anaphylaxis possibly caused by nuts, skin prick test to nuts ≥ 10 mm or specific-IgE ≥ 20 kU/L and have never eaten nuts, or avoids nuts and does not dare try nuts at home). Patients having uncontrolled asthma or other lung disease, having cardiovascular disease or other systemic disease, using beta-blockers, and having poor compliance, are excluded. Methods:The investigators perform skin prick tests to peanut, tree nuts and seeds, take a blood sample before the double-blind placebo-controlled food challenges (DBPCFC), and measure total IgE and specific-IgE to birch, peanut, hazel nut, allergen components Ara h 1, 2, 3, and 8, and Cor a 1 and 8. Then the serum samples are kept frozen for further component and immunologic analyses. The investigators put iv before the challenge. In DBPCFC the patients receive 5 mg, 50 mg, 200mg, and 1000mg nut protein mixt with placebo, or placebo every 30 minutes. The severity of the allergic reaction is estimated using a modified severity scale. The probability of severe/moderate reaction at low (<0.7 kU/L) and at increased (>0.7 kU/L) Ara h 2 and 8 concentrations is the primary end-point in the DBPCFC. The investigators also correlate the concentrations of Ara h 2 with the severity score. Patients with moderate or severe reaction in the challenge will be offered desensitization therapy "SOTI" using(pea)nut flour mixed with milk-free margarine. The first dose of 0.1 mg nut protein is given at hospital part of the up-dosing is made at home every 2 weeks. The patient takes an antihistamine 1 hour before each daily dose. An epinephrine autoinjector and prednisolone tablets are also prescribed for emergency use. The desensitization protocol takes 28 weeks and is personalized when needed. Exercise is avoided 1 hour following each dose. Before and after the SOTI the investigators measure food related quality of life using standardized questionnaires, and perform metacholine challenge and measure exhaled nitric oxid. After the SOTI the investigators take blood samples and perform DBPCFC again.
- Conditions
- Nut Allergy
- Being tested
- Nut challenge, Nut challenge: Placebo, Nut oral desensitization
- Keywords
- Nut allergy, Double-blind placebo-controlled (DBPC) oral nut challenge, Nut oral immunotherapy (OIT), Nut oral desensitization
- Medical subject headings
- Nut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nut challengeDietary supplement
Also called Super nuts banan chips, Yosa oat yoghurt, Arla cowpower chololate pudding
Nut powder made from non-roasted nuts and roasted banana mixed with oats yoghurt or chocolate pudding
Nut challenge: PlaceboDietary supplement
Also called Super nuts banan chips, Yosa oat yoghurt, Arla cowpower chololate pudding
Dried banana mixed with oat yoghurt or chocolate pudding
Nut oral desensitizationDietary supplement
Also called Old Virginia Byrd Mill Fat-Light roasted peanut, Keiju-margarine
Roasted peanut powder mixed with milk- and soy-free margarine
| Study group | Role | What they receive |
|---|---|---|
| Nut challenge | Active comparator | Double-blind placebo controlled oral challenge 5-50-200-1000 mg peanut or hazelnut protein, or placebo administered with 30 min intervals and 2 hour-follow-up after the last dose. Receives: Dietary Supplement: Nut challenge |
| Nut challenge: Placebo | Placebo comparator | See intervention Receives: Dietary Supplement: Nut challenge: Placebo |
| Nut oral desensitization | Experimental | Patients who have moderate to severe immediate allergic reaction at peanut challenge and who enter the oral desensitization program receive peanut protein daily, from 0,1 mg to 800 mg peanut protein, maintenance dose 800 mg. Receives: Dietary Supplement: Nut oral desensitization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of nut oral desensitization
Change from baseline in the amount of nut (mg) tolerated in a double-blind placebo-controlled oral challenge at 1 month after the 6-month oral desensitization therapy.
Measured: 7 months
Secondary outcomes (4)
Effect of the treatment on quality of life
Change from baseline in Quality of life questionnaire square before and after the oral desensitization therapy
Measured: 7 months
Effect of the treatment on bronchial hyperreactivity and airway inflammation
Change from baseline in bronchial hyperreactivity in metacholine challenge and in eosinophilic airway inflammation measured by multiple channel exhaled nitric oxid
Measured: 1 year
Safety of nut oral desensitization therapy
Number of participants with adverse events as a measure of safety and tolerability
Measured: 7 months
Effect of the treatment on eosinophilic airway inflammation
Change from baseline in exhaled nitric oxid concentration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nut AllergyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mika Juhani Mäkelä, MD, PhD, Helsinki University Central Hospital
- Investigators
- Mika J Mäkelä, MD, PhD, Principal investigator, Helsinki UCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502878
- Sponsor's protocol ID
- HUCHT101060080
- Other IDs
- IAS11
- Status last verified
- Sep 2016
- First submitted
- 27 May 2011
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Uotila R, Kukkonen AK, Greco D, Pelkonen AS, Makela MJ. Peanut oral immunotherapy decreases IgE to Ara h 2 and Ara h 6 but does not enhance sensitization to cross-reactive allergens. J Allergy Clin Immunol. 2017 Apr;139(4):1393-1396.e6. doi: 10.1016/j.jaci.2016.09.054. Epub 2016 Dec 1. No abstract available.
PubMed 27916627
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nut Allergy Study: Improving Diagnosis And Treatment Of Nut Allergy
- ClinicalTrials.gov ID
- NCT01502878
- Acronym / sponsor ID
- HUCHT101060080
- Conditions
- Nut Allergy
- Keywords
- Nut allergy, Double-blind placebo-controlled (DBPC) oral nut challenge, Nut oral immunotherapy (OIT), Nut oral desensitization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Jan 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.
Nut sensitization in skin prick tests is common in areas, including Finland, where birch pollen is abundant. However, sensitization to nuts in skin prick test does not predict the possibility of allergic symptoms when nuts are ingested. In this study the investigators launch and perform double-blind placebo-controlled nut challenges and oral desensitization/ protocol to those with serious symptoms in the challenge. The efficacy and safety of the new oral desensitization program is the primary outcome. The effect of oral desensitization on bronchial hyperreactivity, eosinophilic airway inflammation, and quality of life are secondary outcomes.
Detailed description
The investigators aim to improve nut allergy diagnosis by launching a new double-blind placebo-controlled nut (peanut, hazel nut, cashew) challenge protocol. The investigators also launch a specific oral tolerance induction (SOTI) protocol to nuts in serious nut allergy. This study takes place in the Helsinki University Skin and Allergy Hospital between May 2011 and December 2015. Inclusion criteria: age 6 to 18 years and suspected nut allergy (unclear anaphylaxis possibly caused by nuts, skin prick test to nuts ≥ 10 mm or specific-IgE ≥ 20 kU/L and have never eaten nuts, or avoids nuts and does not dare try nuts at home). Patients having uncontrolled asthma or other lung disease, having cardiovascular disease or other systemic disease, using beta-blockers, and having poor compliance, are excluded. Methods:The investigators perform skin prick tests to peanut, tree nuts and seeds, take a blood sample before the double-blind placebo-controlled food challenges (DBPCFC), and measure total IgE and specific-IgE to birch, peanut, hazel nut, allergen components Ara h 1, 2, 3, and 8, and Cor a 1 and 8. Then the serum samples are kept frozen for further component and immunologic analyses. The investigators put iv before the challenge. In DBPCFC the patients receive 5 mg, 50 mg, 200mg, and 1000mg nut protein mixt with placebo, or placebo every 30 minutes. The severity of the allergic reaction is estimated using a modified severity scale. The probability of severe/moderate reaction at low (<0.7 kU/L) and at increased (>0.7 kU/L) Ara h 2 and 8 concentrations is the primary end-point in the DBPCFC. The investigators also correlate the concentrations of Ara h 2 with the severity score. Patients with moderate or severe reaction in the challenge will be offered desensitization therapy "SOTI" using(pea)nut flour mixed with milk-free margarine. The first dose of 0.1 mg nut protein is given at hospital part of the up-dosing is made at home every 2 weeks. The patient takes an antihistamine 1 hour before each daily dose. An epinephrine autoinjector and prednisolone tablets are also prescribed for emergency use. The desensitization protocol takes 28 weeks and is personalized when needed. Exercise is avoided 1 hour following each dose. Before and after the SOTI the investigators measure food related quality of life using standardized questionnaires, and perform metacholine challenge and measure exhaled nitric oxid. After the SOTI the investigators take blood samples and perform DBPCFC again.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nut challenge | Active comparator | Dietary Supplement: Nut challengeDouble-blind placebo controlled oral challenge 5-50-200-1000 mg peanut or hazelnut protein, or placebo administered with 30 min intervals and 2 hour-follow-up after the last dose. |
| Nut challenge: Placebo | Placebo comparator | Dietary Supplement: Nut challenge: PlaceboSee intervention |
| Nut oral desensitization | Experimental | Dietary Supplement: Nut oral desensitizationPatients who have moderate to severe immediate allergic reaction at peanut challenge and who enter the oral desensitization program receive peanut protein daily, from 0,1 mg to 800 mg peanut protein, maintenance dose 800 mg. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- sensitization in skin prick test or in serum nut-specific IgE
- unknown anaphylaxis suspected caused by nuts
- never eaten nuts
- if challenge positive with serious symptoms, OIT
Key exclusion criteria (2 listed)
- active asthma and low lung function,
- pregnancy, cardiovascular or other disease that might worsen during the challenge and OIT
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 |
|---|---|---|
| Nut challengeAlso: Super nuts banan chips, Yosa oat yoghurt, Arla cowpower chololate puddingNut powder made from non-roasted nuts and roasted banana mixed with oats yoghurt or chocolate pudding | Dietary supplement | Nut challenge |
| Nut challenge: PlaceboAlso: Super nuts banan chips, Yosa oat yoghurt, Arla cowpower chololate puddingDried banana mixed with oat yoghurt or chocolate pudding | Dietary supplement | Nut challenge: Placebo |
| Nut oral desensitizationAlso: Old Virginia Byrd Mill Fat-Light roasted peanut, Keiju-margarineRoasted peanut powder mixed with milk- and soy-free margarine | Dietary supplement | Nut oral desensitization |
Primary outcome
Efficacy of nut oral desensitization
Time frame: 7 months
Change from baseline in the amount of nut (mg) tolerated in a double-blind placebo-controlled oral challenge at 1 month after the 6-month oral desensitization therapy.
4 secondary outcomes
Effect of the treatment on quality of life
Time frame: 7 months
Effect of the treatment on bronchial hyperreactivity and airway inflammation
Time frame: 1 year
Safety of nut oral desensitization therapy
Time frame: 7 months
Effect of the treatment on eosinophilic airway inflammation
Time frame: 1 year
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 13 Sep 2016.
- Derived from this study: PubMed 27916627Uotila R, Kukkonen AK, Greco D, Pelkonen AS, Makela MJ. Peanut oral immunotherapy decreases IgE to Ara h 2 and Ara h 6 but does not enhance sensitization to cross-reactive allergens. J Allergy Clin Immunol. 2017 Apr;139(4):1393-1396.e6. doi: 10.1016/j.jaci.2016.09.054. Epub 2016 Dec 1. No abstract available.
Related trials for Nut Allergy
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
Peanut Allergy
RecruitingPhase 1
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
Peanut Allergies
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.
Mika J Mäkelä, MD, PhD principal investigator
Helsinki UCH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nut challenge and Nut oral desensitization in people with Nut Allergy, run by Helsinki University Central Hospital at 2 sites in Finland.
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 2 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 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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. Some participants in this study may receive a placebo. 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?
Efficacy of nut oral desensitization (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01502878, which also lists 1 linked publication.
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 13 Sep 2016.