Evaluation of the Efficacy of Oral Immunotherapy with Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06771791
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Strasbourg, France
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergies

Arms & Interventions

Arms

Experimental: oral immunotherapy

oral immunotherapy with raw apple during 9 month

Placebo Comparator: eviction

avoidance of raw apples for 9 months

Interventions

Other: - oral provocation test

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hôpitaux Universitaires de Strasbourg, Strasbourg, France

Status

Recruiting

Address

Hôpitaux Universitaires de Strasbourg

Strasbourg, , 67000

Site Contact

Anays Dr PIOTIN

[email protected]

+33 03.69.55.00.49

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