Peanut AllergyNCT02979600
Clinical and Biological Efficacy of Peanut Oral Immunotherapy
An observational study of Peanut Allergy, run by Lille Catholic University.
Trial summary
An oral tolerance induction (OTI) protocol is conducted at the allergy Unit of Saint Vincent Hospital of Lille (France) in standard care since 2006. This protocol consists in exposing patients to regularly increasing doses of allergen. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peanut Allergy
- How many people
- 493 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Peanut allergic patients that have followed a peanut oral tolerance induction protocol at the allergy Unit of Saint Vincent Hospital of Lille (France) since 2005
Who may be able to join
- Patients with clinical symptoms when consuming peanuts, such as urticaria, asthma, angioedema, atopic dermatitis, dermo-respiratory syndrome or anaphylactic shock.
- Positive sIgE against r Ara h 2 dosage, i.e. r Ara h 2 >0.1
- Patients that had followed a peanut oral tolerance induction
Who cannot join
- No clinical symptoms or biological confirmation of a peanut allergy
About this study
An oral tolerance induction (OTI) protocol is conducted at the allergy Unit of Saint Vincent Hospital of Lille (France) in standard care since 2006. This protocol consists in exposing patients to regularly increasing doses of allergen. This protocol induces an increase of the threshold reactive dose (the minimum dose of allergen that triggered a reactive reaction) and a decrease of the quantity of specific immunoglobulin E (sIgE) against peanut proteins. The protocol is ended when the patient reaches a threshold reactive dose of 2942mg of peanut proteins, corresponding to 14 peanuts of middle size, which is the maximum dose of peanut that can be found in standard product in France.
The investigators wish to study the evolution of the threshold reactive dose and of the sIgE of patients that have followed the OTI protocol. All the needed data are available in the medical records so the study will be conducted on retrospective data.
Read the detailed description
Prevalence of food allergy is estimated at 3.5% in Europe. In particular, peanut allergy prevalence in France is between 0.3% and 0.75%, when it is 1% in the US, UK and Canada. Peanut allergy is a severe allergy, second behind tree nut allergy in the general population, with a risk of fatal reactions. The risk is especially high for young adults. It is also a long lasting condition with only 20% of natural healing that happened most of the time between 6 and 8y.o. These last years, the only proposed "treatment" was an elimination diet. However, it has been proved that it makes allergy severity worse, and sensitization and reactivity increase with time. Elimination diet can also lead to the apparition of avoidant/restrictive food intake disorders, and has a major impact on patient habits, causing patient quality of life to decrease.
In view of the risks and limits of an elimination diet and the low natural healing rate, a therapeutic alternative has been proposed with the development of peanut oral tolerance induction (OTI) protocols. As sublingual immunotherapies have low efficacies and as injection strategies have a high risk of severe allergic reactions, oral route is preferred. This strategy needs to ensure patients an increasing tolerance to the allergen, thus limiting the risks of anaphylactic shock at low doses, but also needs to ensure patient safety, with controlled risks of secondary reactions at home. It can be followed by young patients, its efficiency being increased. An OTI protocol is conducted at the allergy Unit of Saint Vincent Hospital of Lille (France) in standard care since 2006. It consists in daily giving small peanut doses to the patient, and to regularly increase those doses.
For this OTI protocol, an oral food challenge (OFC) is performed. This OFC allows the determination of the threshold reactive dose, i.e. the minimum dose of allergen that induces an allergic reaction. A safe dose of peanut is then determined that will be regularly eaten by the patient. Every 6 months, a new OFC is performed and thus a new threshold reactive dose is measured, and the dose to be eaten by the patient updated. The protocol is followed until the patient reaches an ideal dose of 2942mg of peanut protein, corresponding to 14 peanuts of middle size, which is the maximum dose of peanut that can be found in standard product in France. Of course, the protocol can also be ended if the patient decided so.
Although this protocol is performed in the allergy Unit of Saint Vincent Hospital, very few data are published on the subject. The aim of the study is to study the evolution of the threshold reactive dose and the evolution of the quantity of specific immunoglobulin E (sIgE) against peanut proteins (rAra h 1, rAra h 2 and rAra h 3) in patient that had followed the protocol.
The main objective of this study is to study the clinical efficiency of peanut OTI by measuring the evolution of the patient threshold reactive dose.
The secondary objective is to study the biological efficiency of peanut OTI by measuring the evolution of the dosage of sIgE against peanut proteins.
As the OFC and the IgE dosage are a standard part of the OTI protocol, all the data are obtained from the medical records. The study is retrospective and thus observational.
- Conditions
- Peanut Allergy
- Keywords
- Oral immunotherapy, Oral tolerance induction
- Medical subject headings
- Peanut Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the threshold reactive dose in milligrams
During the OTI protocol, an oral food challenge is performed every 6 months. The dose that induce the first allergic reaction is reported. The protocol is followed until the patients get a threshold reactive dose of 2942mg of peanut protein, or until the patient decide to end it.
Measured: At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 years)
Secondary outcomes (1)
Evolution of IgE dosages against Arah1, 2 and 3
Dosage of the specific IgE against peanut proteins, rAra h 1, rAra h 2 and rArah 3, that are performed every 6 months during the standard follow-up of the patients. The measures are done with ImmunoCAP laboratory system, Phadia, Uppsala, Sweden.
Measured: At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Seynave, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979600
- Sponsor's protocol ID
- OBS-051
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2016
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Efficacy of Peanut Oral Immunotherapy
- ClinicalTrials.gov ID
- NCT02979600
- Acronym / sponsor ID
- OBS-051
- Conditions
- Peanut Allergy
- Keywords
- Oral immunotherapy, Oral tolerance induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Dec 2016 (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.
An oral tolerance induction (OTI) protocol is conducted at the allergy Unit of Saint Vincent Hospital of Lille (France) in standard care since 2006. This protocol consists in exposing patients to regularly increasing doses of allergen. This protocol induces an increase of the threshold reactive dose (the minimum dose of allergen that triggered a reactive reaction) and a decrease of the quantity of specific immunoglobulin E (sIgE) against peanut proteins. The protocol is ended when the patient reaches a threshold reactive dose of 2942mg of peanut proteins, corresponding to 14 peanuts of middle size, which is the maximum dose of peanut that can be found in standard product in France.
The investigators wish to study the evolution of the threshold reactive dose and of the sIgE of patients that have followed the OTI protocol. All the needed data are available in the medical records so the study will be conducted on retrospective data.
Detailed description
Prevalence of food allergy is estimated at 3.5% in Europe. In particular, peanut allergy prevalence in France is between 0.3% and 0.75%, when it is 1% in the US, UK and Canada. Peanut allergy is a severe allergy, second behind tree nut allergy in the general population, with a risk of fatal reactions. The risk is especially high for young adults. It is also a long lasting condition with only 20% of natural healing that happened most of the time between 6 and 8y.o. These last years, the only proposed "treatment" was an elimination diet. However, it has been proved that it makes allergy severity worse, and sensitization and reactivity increase with time. Elimination diet can also lead to the apparition of avoidant/restrictive food intake disorders, and has a major impact on patient habits, causing patient quality of life to decrease.
In view of the risks and limits of an elimination diet and the low natural healing rate, a therapeutic alternative has been proposed with the development of peanut oral tolerance induction (OTI) protocols. As sublingual immunotherapies have low efficacies and as injection strategies have a high risk of severe allergic reactions, oral route is preferred. This strategy needs to ensure patients an increasing tolerance to the allergen, thus limiting the risks of anaphylactic shock at low doses, but also needs to ensure patient safety, with controlled risks of secondary reactions at home. It can be followed by young patients, its efficiency being increased. An OTI protocol is conducted at the allergy Unit of Saint Vincent Hospital of Lille (France) in standard care since 2006. It consists in daily giving small peanut doses to the patient, and to regularly increase those doses.
For this OTI protocol, an oral food challenge (OFC) is performed. This OFC allows the determination of the threshold reactive dose, i.e. the minimum dose of allergen that induces an allergic reaction. A safe dose of peanut is then determined that will be regularly eaten by the patient. Every 6 months, a new OFC is performed and thus a new threshold reactive dose is measured, and the dose to be eaten by the patient updated. The protocol is followed until the patient reaches an ideal dose of 2942mg of peanut protein, corresponding to 14 peanuts of middle size, which is the maximum dose of peanut that can be found in standard product in France. Of course, the protocol can also be ended if the patient decided so.
Although this protocol is performed in the allergy Unit of Saint Vincent Hospital, very few data are published on the subject. The aim of the study is to study the evolution of the threshold reactive dose and the evolution of the quantity of specific immunoglobulin E (sIgE) against peanut proteins (rAra h 1, rAra h 2 and rAra h 3) in patient that had followed the protocol.
The main objective of this study is to study the clinical efficiency of peanut OTI by measuring the evolution of the patient threshold reactive dose.
The secondary objective is to study the biological efficiency of peanut OTI by measuring the evolution of the dosage of sIgE against peanut proteins.
As the OFC and the IgE dosage are a standard part of the OTI protocol, all the data are obtained from the medical records. The study is retrospective and thus observational.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Peanut allergic patients that have followed a peanut oral tolerance induction protocol at the allergy Unit of Saint Vincent Hospital of Lille (France) since 2005
Key inclusion criteria (3 listed)
- Patients with clinical symptoms when consuming peanuts, such as urticaria, asthma, angioedema, atopic dermatitis, dermo-respiratory syndrome or anaphylactic shock.
- Positive sIgE against r Ara h 2 dosage, i.e. r Ara h 2 >0.1
- Patients that had followed a peanut oral tolerance induction
Key exclusion criteria (1 listed)
- No clinical symptoms or biological confirmation of a peanut allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of the threshold reactive dose in milligrams
Time frame: At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 years)
During the OTI protocol, an oral food challenge is performed every 6 months. The dose that induce the first allergic reaction is reported. The protocol is followed until the patients get a threshold reactive dose of 2942mg of peanut protein, or until the patient decide to end it.
1 secondary outcome
Evolution of IgE dosages against Arah1, 2 and 3
Time frame: At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 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 1 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Maxime Seynave, MD principal investigator
GHICL
Questions about this trial
What is this clinical trial studying?
An observational study of Peanut Allergy, run by Lille Catholic University.
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 1 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 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Evolution of the threshold reactive dose in milligrams (time frame: At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 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 1 Dec 2016.