AllergiesPhase 3ELIONCT06771791
Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study
A Phase 3 study testing oral provocation test in people with Allergies, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
Apple-birch pollen-food allergy syndrome is particularly common in Northern and Central Europe (70% of patients allergic to birch pollen), and classically induces an oral syndrome that impairs patients' quality of life. Current treatment is based on food avoidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergies
- What is being tested?
- oral provocation test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Jan 2025to 5 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with allergic rhinitis to birch pollen.
- Patient with an oral syndrome within 15 minutes of consuming at least one of the first 3 doses of raw apple in the V0 or V1 raw apple oral challenge test.
- Evidence of sensitization to PR10 proteins in birch pollen and apple: positive prick tests to birch pollen and raw Golden apple and/or positive Bet v 1 and Mal d 1 specific IgE assays.
- Subject affiliated to a social health insurance scheme
- Subject able to understand the aims and risks of the research and to give dated and signed informed consent
- For women of childbearing age: negative urine pregnancy test at inclusion visit
Who cannot join
- Severe or uncontrolled asthma
- Severe obstructive syndrome
- Active neoplastic disease
- Active autoimmune disease
- Eosinophilic esophagitis or other active eosinophilic gastrointestinal pathologies
- History of bariatric surgery
Show all 18Show fewer
- History of anaphylaxis to apples
- Allergy to cooked apples
- Contraindication to anti-histamines, corticoids, salbutamol, adrenaline
- Other contraindication to an oral challenge test
- Allergy to placebo ingredients
- Presence of oral syndrome during consumption of placebo in the first oral challenge test
- Allergenic immunotherapy to birch pollen in progress or completed less than 5 years ago
- Current treatment with anti-IgE, anti-IL4/13, anti-IL5 or anti-TSLP biotherapy.
- Impossibility of giving the subject informed information
- Subject under court protection
- Subject under guardianship or curatorship
- Pregnancy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Chu Jean Minjoz
Besançon, 25030
Fabien PELLETIER, Doctor, +33 381416060 ext. +33, fpelletier@chu-besancon.fr
- Recruiting
Hopital François Mitterrand Chu Dijon
Dijon, 21079
Philippe BONNIAUS, Professor, +33 380293772 ext. +33, philippe.bonniaud@chu-dijon.fr
- Not yet recruiting
Hopital Maison Blanche Chu Reims
Reims, 51092
Jeanne-Marie PEROTIN-COLLARD, Professor, +33 326787609 ext. +33, jmperotin-collard@chu-reims.fr
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Anays Dr PIOTIN, +33 03.69.55.00.49, anays.piotin@chru-strasbourg.fr
About this study
Apple-birch pollen-food allergy syndrome is particularly common in Northern and Central Europe (70% of patients allergic to birch pollen), and classically induces an oral syndrome that impairs patients' quality of life. Current treatment is based on food avoidance. However, evidence of the efficacy of this treatment is limited (small numbers, lack of validation with a control group, absence of double-blind evaluation of the primary endpoint in a challenge test against placebo). The aim of oral immunotherapy with raw apple is to improve the management of allergic patients by enabling them to acquire tolerance to raw apple and other rosacea.
- Conditions
- Allergies
- Being tested
- oral provocation test
- Keywords
- allergy, oral immunotherapy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral provocation testOther
Progressively increasing doses of peeled fresh Golden apple or placebo will be consumed by the patient (4g, 12g, 40g, 120g) with a time interval of 20 minutes between each dose.
| Study group | Role | What they receive |
|---|---|---|
| oral immunotherapy | Experimental | oral immunotherapy with raw apple during 9 month Receives: Other: oral provocation test |
| eviction | Placebo comparator | avoidance of raw apples for 9 months Receives: Other: oral provocation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome
To evaluate the efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome after 9 months of oral immunotherapy. A reduction in oral syndrome after 9 months of oral immunotherapy with raw apple is defined as: absence of oral syndrome on the 9-month raw apple OPT when consuming a dose of raw apple 3 times greater than the dose of raw apple triggering oral syndrome on the initial raw apple oral challenge.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start8 Jan 2025
- Primary completion5 May 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergiesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771791
- Sponsor's protocol ID
- 9432
- Acronym
- ELIO
- Status last verified
- May 2026
- First submitted
- 7 Jan 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study
- ClinicalTrials.gov ID
- NCT06771791
- Acronym / sponsor ID
- ELIO / 9432
- Conditions
- Allergies
- Keywords
- allergy, oral immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- 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.
Apple-birch pollen-food allergy syndrome is particularly common in Northern and Central Europe (70% of patients allergic to birch pollen), and classically induces an oral syndrome that impairs patients' quality of life. Current treatment is based on food avoidance. However, evidence of the efficacy of this treatment is limited (small numbers, lack of validation with a control group, absence of double-blind evaluation of the primary endpoint in a challenge test against placebo). The aim of oral immunotherapy with raw apple is to improve the management of allergic patients by enabling them to acquire tolerance to raw apple and other rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral immunotherapy | Experimental | Other: oral provocation testoral immunotherapy with raw apple during 9 month |
| eviction | Placebo comparator | Other: oral provocation testavoidance of raw apples for 9 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with allergic rhinitis to birch pollen.
- Patient with an oral syndrome within 15 minutes of consuming at least one of the first 3 doses of raw apple in the V0 or V1 raw apple oral challenge test.
- Evidence of sensitization to PR10 proteins in birch pollen and apple: positive prick tests to birch pollen and raw Golden apple and/or positive Bet v 1 and Mal d 1 specific IgE assays.
- Subject affiliated to a social health insurance scheme
- Subject able to understand the aims and risks of the research and to give dated and signed informed consent
Key exclusion criteria (18 listed)
- Severe or uncontrolled asthma
- Severe obstructive syndrome
- Active neoplastic disease
- Active autoimmune disease
- Eosinophilic esophagitis or other active eosinophilic gastrointestinal pathologies
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 |
|---|---|---|
| oral provocation testProgressively increasing doses of peeled fresh Golden apple or placebo will be consumed by the patient (4g, 12g, 40g, 120g) with a time interval of 20 minutes between each dose. | Other | eviction, oral immunotherapy |
Primary outcome
Efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome
Time frame: 9 month
To evaluate the efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome after 9 months of oral immunotherapy. A reduction in oral syndrome after 9 months of oral immunotherapy with raw apple is defined as: absence of oral syndrome on the 9-month raw apple OPT when consuming a dose of raw apple 3 times greater than the dose of raw apple triggering oral syndrome on the initial raw apple oral challenge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral provocation test in people with Allergies, run by University Hospital, Strasbourg, France at 4 sites 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 6 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anays PIOTIN, Dr (+33 03.69.55.00.49, anays.piotin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome (time frame: 9 month). 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 26 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.