Allergy to EggPhase 4TAB-TPONCT01966640
Basophil Activation Test (BAT) Sensitivity in Child Food Allergy
A Phase 4 study testing Basophil Activation Test in people with Allergy to Egg and Allergy to Peanut, run by University Hospital, Rouen at 1 site in France.
Trial summary
Child food allergy represent 6 to 8% of child in industrialised country. Within this allergy, peanuts and egg allergy are one of the most common. Actually when there is a suspicion of food allergy, the OPT is the gold standard for the diagnosis. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Allergy to Egg, Allergy to Peanut
- What is being tested?
- Basophil Activation Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2013to 11 Jan 2019
- Phase
- Phase 4
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child older than 6 months and less than 18 years old
- Diagnosis of type I allergy to peanut or egg
- oral provocation test to peanut or egg programmed
Who cannot join
- No possibility to assess blood sample
Trial locations and contacts
1 site in 1 country.
About this study
Child food allergy represent 6 to 8% of child in industrialised country. Within this allergy, peanuts and egg allergy are one of the most common.
Actually when there is a suspicion of food allergy, the OPT is the gold standard for the diagnosis. During the OPT we give increasing doses of the allergen to the patient and evaluate threshold causing a clinical reaction. This test is associated with a risk of strong allergic reaction and need a medical supervision.
Read more
Standard allergy test, like skin test or specific IgE test, can't be use for the diagnosis of these allergy. Some publications demonstrate that these tests lack sensibility and specificity for child food allergy diagnosis.
New tests have to be develop to diagnosis child food allergy without risks. The BAT is a cellular test able to evaluate the basophiles activation by specific allergen in vitro. This test allow us to evaluate more physiologically the sensitization of patients to an allergen. It is already used in drug allergy and it has been evaluated in infant milk allergy in an other clinical trial.
In this study we want to evaluate the sensitivity of BAT to the diagnosis of child food allergy compare to the gold standard test OPT. We will evaluate the BAT on 140 children with food allergy and compare this results with the OPT at the same time. If the BAT results can predict the sensitivity of children to food allergen, it could limit the use of the OPT and reduce the risk of this test.
Read the detailed description
Child food allergy represent 6 to 8% of child in industrialised country. One third of these child will develop severe reactions and one third will experience multiple allergy. In France, there is few epidemiologic data but in 2005 F. Rancé evaluated the prevalence of these allergy to 6.7% of school child. Within the food allergen, peanut, egg and milk are the most common.
Currently, there is two diagnostic possibilities:
- A strong allergic reaction with identified allergens and specific IgE positive, making it highly probable diagnosis.
- A moderate allergic reaction with only suspicion on the allergen, without definitive diagnosis.
When there is a suspected allergy, the gold standard to the diagnosis is the OPT. This test consist of the gradual ingestion of the suspected food allergen to evaluate the threshold causing a clinical reaction. The OPT must be performed under medical supervision in a hospital due to the risk of severe allergic reaction.
The OPT is the gold standard in allergy diagnosis. The other tests (prick test, IgE specific measure…) are not sensitive enough. Furthermore, the level of IgE specific was not related to the risk to develop clinical reaction to the food allergen. Some studies have try to combine skin tests with the result of IgE specific measure but the sensitivity did not improve enough.
New tests have to be develop to diagnosis child food allergy without risks. The BAT is a cellular test able to evaluate, in blood, the basophiles activation by specific allergen in vitro. This test measure by flow cytométrie the expression of activation molecule (CD63) on basophiles (CCR3+) after incubation with the allergen. If the patient is sensitize to the allergen, the percentage of active basophiles will be higher than in non sensitize people. This test allow us to evaluate more physiologically the sensitization of patients to an allergen. This test has already been tested for drug allergy and milk allergy in child. This clinical trial demonstrated that in mill allergy, the BAT had a good sensitivity (91% and sensibility (96%). Furthermore, this study could determined the threshold of the BAT in child food allergy (6% of activated basophiles).
In light of these results, we want to evaluate the advantage of BAT compare to OPT in child with allergy to egg or peanut.
During this study, we will perform BAT on a blood sample from child suspected of food allergy (egg or peanut) before OPT and we will compare its results with the OPT results. The primary objective of this study is to evaluate the BAT interest to predict the results of OPT by analysing the sensibility, specificity, positive predictive value, negative predictive value of BAT.
If these study demonstrate that BAT can predict OPT results for child food allergy, we will be able to reduce the number of OPT for these patients and reduce the risk of anaphylactic shock during OPT.
- Conditions
- Allergy to Egg, Allergy to Peanut
- Being tested
- Basophil Activation Test
- Keywords
- diagnosis of allergy, Basophil Activation Test
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basophil Activation TestBiological
blood sample for Basophil Activation Test
| Study group | Role | What they receive |
|---|---|---|
| Child food allergy suspicion | Experimental | Basophil Activation Test realized in case of Child food egg and peanut allergy suspicion Receives: Biological: Basophil Activation Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the Basophil Activation Test
Sensitivity of the BAT compare to OPT with a threshold value of 6% for the BAT in a population of child food allergy.
Sensitivity is defined as the capacity for BAT to have a positive result when OAT result is also positive (diagnosis of allergy confirmed)
Measured: Day 1
Secondary outcomes (1)
Evaluation of the proportion of child positive to the BAT
Evaluation of the proportion of child positive to the BAT within child positive to the OPT in the group egg allergy Evaluation of the proportion of child positive to the BAT within child positive to the OPT in the group peanut allergy
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study start12 Sep 2013
- Primary completion11 Jan 2019
- Study completion11 Jan 2019
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 Allergy to EggStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure COUDERC, Dr, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966640
- Sponsor's protocol ID
- 2012/170/HP
- Acronym
- TAB-TPO
- Status last verified
- Apr 2026
- First submitted
- 11 Oct 2013
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Carrette M, Couderc L, Bubenheim M, Vidal A, Youssouf A, Boyer O, Marguet C, Martinet J. The combination of Ara h 2-sIgE and basophil activation test could be an alternative to oral food challenge in cases of suspected peanut allergy. Pediatr Allergy Immunol. 2023 Aug;34(8):e14007. doi: 10.1111/pai.14007.
PubMed 37622254
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basophil Activation Test (BAT) Sensitivity in Child Food Allergy
- ClinicalTrials.gov ID
- NCT01966640
- Acronym / sponsor ID
- TAB-TPO / 2012/170/HP
- Conditions
- Allergy to Egg, Allergy to Peanut
- Keywords
- diagnosis of allergy, Basophil Activation Test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 12 Sep 2013 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 21 Oct 2013 (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.
Child food allergy represent 6 to 8% of child in industrialised country. Within this allergy, peanuts and egg allergy are one of the most common.
Actually when there is a suspicion of food allergy, the OPT is the gold standard for the diagnosis. During the OPT we give increasing doses of the allergen to the patient and evaluate threshold causing a clinical reaction. This test is associated with a risk of strong allergic reaction and need a medical supervision.
Standard allergy test, like skin test or specific IgE test, can't be use for the diagnosis of these allergy. Some publications demonstrate that these tests lack sensibility and specificity for child food allergy diagnosis.
New tests have to be develop to diagnosis child food allergy without risks. The BAT is a cellular test able to evaluate the basophiles activation by specific allergen in vitro. This test allow us to evaluate more physiologically the sensitization of patients to an allergen. It is already used in drug allergy and it has been evaluated in infant milk allergy in an other clinical trial.
In this study we want to evaluate the sensitivity of BAT to the diagnosis of child food allergy compare to the gold standard test OPT. We will evaluate the BAT on 140 children with food allergy and compare this results with the OPT at the same time. If the BAT results can predict the sensitivity of children to food allergen, it could limit the use of the OPT and reduce the risk of this test.
Detailed description
Child food allergy represent 6 to 8% of child in industrialised country. One third of these child will develop severe reactions and one third will experience multiple allergy. In France, there is few epidemiologic data but in 2005 F. Rancé evaluated the prevalence of these allergy to 6.7% of school child. Within the food allergen, peanut, egg and milk are the most common.
Currently, there is two diagnostic possibilities:
- A strong allergic reaction with identified allergens and specific IgE positive, making it highly probable diagnosis.
- A moderate allergic reaction with only suspicion on the allergen, without definitive diagnosis.
When there is a suspected allergy, the gold standard to the diagnosis is the OPT. This test consist of the gradual ingestion of the suspected food allergen to evaluate the threshold causing a clinical reaction. The OPT must be performed under medical supervision in a hospital due to the risk of severe allergic reaction.
The OPT is the gold standard in allergy diagnosis. The other tests (prick test, IgE specific measure…) are not sensitive enough. Furthermore, the level of IgE specific was not related to the risk to develop clinical reaction to the food allergen. Some studies have try to combine skin tests with the result of IgE specific measure but the sensitivity did not improve enough.
New tests have to be develop to diagnosis child food allergy without risks. The BAT is a cellular test able to evaluate, in blood, the basophiles activation by specific allergen in vitro. This test measure by flow cytométrie the expression of activation molecule (CD63) on basophiles (CCR3+) after incubation with the allergen. If the patient is sensitize to the allergen, the percentage of active basophiles will be higher than in non sensitize people. This test allow us to evaluate more physiologically the sensitization of patients to an allergen. This test has already been tested for drug allergy and milk allergy in child. This clinical trial demonstrated that in mill allergy, the BAT had a good sensitivity (91% and sensibility (96%). Furthermore, this study could determined the threshold of the BAT in child food allergy (6% of activated basophiles).
In light of these results, we want to evaluate the advantage of BAT compare to OPT in child with allergy to egg or peanut.
During this study, we will perform BAT on a blood sample from child suspected of food allergy (egg or peanut) before OPT and we will compare its results with the OPT results. The primary objective of this study is to evaluate the BAT interest to predict the results of OPT by analysing the sensibility, specificity, positive predictive value, negative predictive value of BAT.
If these study demonstrate that BAT can predict OPT results for child food allergy, we will be able to reduce the number of OPT for these patients and reduce the risk of anaphylactic shock during OPT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Child food allergy suspicion | Experimental | Biological: Basophil Activation TestBasophil Activation Test realized in case of Child food egg and peanut allergy suspicion |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Child older than 6 months and less than 18 years old
- Diagnosis of type I allergy to peanut or egg
- oral provocation test to peanut or egg programmed
Key exclusion criteria (1 listed)
- No possibility to assess blood sample
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 |
|---|---|---|
| Basophil Activation Testblood sample for Basophil Activation Test | Biological | Child food allergy suspicion |
Primary outcome
Sensitivity of the Basophil Activation Test
Time frame: Day 1
Sensitivity of the BAT compare to OPT with a threshold value of 6% for the BAT in a population of child food allergy. Sensitivity is defined as the capacity for BAT to have a positive result when OAT result is also positive (diagnosis of allergy confirmed)
1 secondary outcome
Evaluation of the proportion of child positive to the BAT
Time frame: Day 1
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 16 Apr 2026.
- Results publication: PubMed 37622254Carrette M, Couderc L, Bubenheim M, Vidal A, Youssouf A, Boyer O, Marguet C, Martinet J. The combination of Ara h 2-sIgE and basophil activation test could be an alternative to oral food challenge in cases of suspected peanut allergy. Pediatr Allergy Immunol. 2023 Aug;34(8):e14007. doi: 10.1111/pai.14007.
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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.
Laure COUDERC, Dr principal investigator
UH Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Basophil Activation Test in people with Allergy to Egg and Allergy to Peanut, run by University Hospital, Rouen at 1 site in France.
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 16 Apr 2026. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sensitivity of the Basophil Activation Test (time frame: Day 1). 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 NCT01966640, 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 16 Apr 2026.