Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT07073404
Eligibility Criteria:
Inclusion Criteria:
* Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.
* Allergy to plant foods due to sensitisation to LTP, patients allergic to profilin confirmed by a suggestive clinical history, positive skin tests and specific IgE to Pru p 3 (peach LTP) and Pho d 2 (Phoenix dactylifera profilin).
* Positive oral challenge test (OPT) to peach and at least one other food in patients allergic to LTP and positive oral challenge test to melon and at least one other food in patients allergic to profilin.
* Selection of a group of LTP-allergic individuals with therapeutic failure after treatment with ITSL-Pru p 3.
Exclusion Criteria:
* Pregnancy and lactation.
* Immunological diseases; treatment with immunomodulatory and/or blocking drugs.
* Mental illness, which makes it impossible to follow and adhere to treatment (e.g. major depression, psychosis, etc.).
* Severe atopic dermatitis according to SCORAD 5: FEV1\<70% (this test will be carried out as a priority in patients with a previous diagnosis of asthma).
* Inflammation in the oral cavity with severe symptoms, as well as with oral surgery in the previous 7 days.
* Immunotherapy with pollens in the previous 2 years.
* Subjects unable to comply with the schedule of visits during the study, as well as due to the consumption of the food under investigation, for example, due to work difficulties.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
55 Years
Study:
NCT07073404
Study Brief:
Protocol Section:
NCT07073404