Clinical and Biological Efficacy of Hazelnut Oral Immunotherapy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03048149
• Date of registration: 07/02/2017
• Prospective Registration: No
• Primary sponsor: Lille Catholic University
• Public title: Clinical and Biological Efficacy of Hazelnut Oral Immunotherapy
• Scientific title: Clinical and Biological Efficacy of Hazelnut Oral Immunotherapy
• Date of first enrolment: December 1, 2016
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03048149
• Study type: Observational

Countries of recruitment

France

Contacts

• Name: Tomas Moraly
• Affiliation: GHICL

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with clinical symptoms when consuming hazelnuts, such as urticaria, asthma,
angioedema, atopic dermatitis, dermo-respiratory syndrome or anaphylactic shock.

- Positive sIgE against hazelnut, r Cor a 1, 8, 9 or 14

- Patients that had followed a hazelnut oral tolerance induction

Exclusion Criteria:

- No clinical symptoms or biological confirmation of a hazelnut allergy



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Allergy

Primary Outcome(s)

Evolution of the threshold reactive dose in milligrams [Time Frame: At inclusion, then every 6 months until a threshold reactive dose of 11 766mg of hazelnut protein is reached (up to 5 years)]

Secondary Outcome(s)

Evolution of the size of the prick test [Time Frame: At inclusion, then every 6 months until a threshold reactive dose of 11 766mg of hazelnut protein is reached (up to 5 years)]

Evolution of IgE dosages against hazelnut proteins, r Cor a 1, 8, 9 or 14 [Time Frame: At inclusion, then every 6 months until a threshold reactive dose of 11 766mg of hazelnut protein is reached (up to 5 years)]

Secondary ID(s)

OBS-143

Source(s) of Monetary Support

Please refer to primary and secondary sponsors