Food HypersensitivityNCT02457416
Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut
A study testing Peanut in people with Food Hypersensitivity, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of the study is to identify prognostic markers and possible success rate of tolerance induction to peanut allergens in children allergic to peanut. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Food Hypersensitivity
- What is being tested?
- Peanut
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2014to Mar 2019
- 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 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Positive skin prick test or IgE to peanut
- Age 5-15 yrs
- Primary peanut allergy verified by objective symptoms to DBPCFC by a dose of 3 mg or more peanut potein
Who cannot join
- Non controlled asthma (by asthma control test, ACT)
- Allergy/intolerance to any other ingredients in the vehicle used for the peanut DBPCFC
- Current or previous allergen specific immunotherapy
- Cardiac disease with increased risk of serious anaphylaxis
- Severe atopic skin disease
- Diabetes mellitus
- Severe disease that interferes with adherence to study protocol
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to identify prognostic markers and possible success rate of tolerance induction to peanut allergens in children allergic to peanut.
Read the detailed description
The study is an open randomized controlled study on oral immunotherapy including 60 children (40 on active treatment, 20 controls) with primary peanut allergy. The study has 4 phases: 1: inclusion/randomization including a double blind placebo controlled food Challenge 2: bi weekly up-dosing to maintenance dose after 48 weeks, 3: maintenance period of 3 years 4: 1 year follow up after end of treatment.
Clinical parameters as well as immunological (serological and cellular) will be recorded at inclusion, after 3 months of up-dosing, at end of up-dosing, after 1 and 3 years of maintenance treatment and after 3 and 12 year of follow up.
- Conditions
- Food Hypersensitivity
- Being tested
- Peanut
- Keywords
- Peanut allergy, Oral immunotherapy
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeanutOther
Treatment with peanut in increasing doses until a maintenance dose
| Study group | Role | What they receive |
|---|---|---|
| Peanut oral immunotherapy | Active comparator | Oral immunotherapy with peanut Receives: Other: Peanut |
| Controls | No intervention | Avoid peanut exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with successfull tolerance induction to peanut
Measured: Data will be recorded for 5 years
Secondary outcomes (2)
Clinical prognostic markers for successful tolerance induction to peanut
Clinical markers like severity of peanut allergy during double blind placebo controlled food challenge (DBPCFC), threshold level on DBPCFC, side effects during up dosing, maximum peanut dose reached, concomitant other atopic diseases will be assessed
Measured: Data will be recorded for 5 years
Immunological prognostic markers for successful tolerance induction to peanut
Immunologic markers: Immunoglobulin E (IgE) to peanut and its components, total IgE, Immunoglobulin G4 to peanut and its components, Basophil activation test will be assessed.
Measured: Data will be recorded for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMar 2014
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geir Håland, Oslo University Hospital
- Investigators
- Geir Håland, MD PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457416
- Sponsor's protocol ID
- 2013/430
- Status last verified
- May 2016
- First submitted
- 30 May 2014
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reier-Nilsen T, Carlsen KCL, Michelsen MM, Drottning S, Carlsen KH, Zhang C, Borres MP, Haland G. Parent and child perception of quality of life in a randomized controlled peanut oral immunotherapy trial. Pediatr Allergy Immunol. 2019 Sep;30(6):638-645. doi: 10.1111/pai.13066. Epub 2019 Jul 25.
PubMed 31013372Reier-Nilsen T, Michelsen MM, Lodrup Carlsen KC, Carlsen KH, Mowinckel P, Nygaard UC, Namork E, Borres MP, Haland G. Feasibility of desensitizing children highly allergic to peanut by high-dose oral immunotherapy. Allergy. 2019 Feb;74(2):337-348. doi: 10.1111/all.13604. Epub 2018 Oct 8.
PubMed 30225844
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut
- ClinicalTrials.gov ID
- NCT02457416
- Acronym / sponsor ID
- 2013/430
- Conditions
- Food Hypersensitivity
- Keywords
- Peanut allergy, Oral immunotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 29 May 2015 (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 purpose of the study is to identify prognostic markers and possible success rate of tolerance induction to peanut allergens in children allergic to peanut.
Detailed description
The study is an open randomized controlled study on oral immunotherapy including 60 children (40 on active treatment, 20 controls) with primary peanut allergy. The study has 4 phases: 1: inclusion/randomization including a double blind placebo controlled food Challenge 2: bi weekly up-dosing to maintenance dose after 48 weeks, 3: maintenance period of 3 years 4: 1 year follow up after end of treatment.
Clinical parameters as well as immunological (serological and cellular) will be recorded at inclusion, after 3 months of up-dosing, at end of up-dosing, after 1 and 3 years of maintenance treatment and after 3 and 12 year of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut oral immunotherapy | Active comparator | Other: PeanutOral immunotherapy with peanut |
| Controls | No intervention | –Avoid peanut exposure |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Positive skin prick test or IgE to peanut
- Age 5-15 yrs
- Primary peanut allergy verified by objective symptoms to DBPCFC by a dose of 3 mg or more peanut potein
Key exclusion criteria (7 listed)
- Non controlled asthma (by asthma control test, ACT)
- Allergy/intolerance to any other ingredients in the vehicle used for the peanut DBPCFC
- Current or previous allergen specific immunotherapy
- Cardiac disease with increased risk of serious anaphylaxis
- Severe atopic skin disease
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 |
|---|---|---|
| PeanutTreatment with peanut in increasing doses until a maintenance dose | Other | Peanut oral immunotherapy |
Primary outcome
Number of participants with successfull tolerance induction to peanut
Time frame: Data will be recorded for 5 years
2 secondary outcomes
Clinical prognostic markers for successful tolerance induction to peanut
Time frame: Data will be recorded for 5 years
Immunological prognostic markers for successful tolerance induction to peanut
Time frame: Data will be recorded for 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Derived from this study: PubMed 31013372Reier-Nilsen T, Carlsen KCL, Michelsen MM, Drottning S, Carlsen KH, Zhang C, Borres MP, Haland G. Parent and child perception of quality of life in a randomized controlled peanut oral immunotherapy trial. Pediatr Allergy Immunol. 2019 Sep;30(6):638-645. doi: 10.1111/pai.13066. Epub 2019 Jul 25.
- Derived from this study: PubMed 30225844Reier-Nilsen T, Michelsen MM, Lodrup Carlsen KC, Carlsen KH, Mowinckel P, Nygaard UC, Namork E, Borres MP, Haland G. Feasibility of desensitizing children highly allergic to peanut by high-dose oral immunotherapy. Allergy. 2019 Feb;74(2):337-348. doi: 10.1111/all.13604. Epub 2018 Oct 8.
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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.
Geir Håland, MD PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut in people with Food Hypersensitivity, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 May 2016. 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 Norway. 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?
Results are not available in the source record.
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?
Number of participants with successfull tolerance induction to peanut (time frame: Data will be recorded for 5 years). 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 NCT02457416, which also lists 2 linked publications.
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 4 May 2016.