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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT07107451
Eligibility Criteria:
Inclusion criteria:
* Sesame allergy confirmed before starting immunotherapy
* Completion of the first part of the study - achieving the maintenance dose (300mg sesame protein) during immunotherapy
* Obtaining informed consent to participate in the study,
* Patient/carer cooperation.
Exclusion criteria:
* Severe asthma,
* Mild/moderate poorly controlled asthma: FEV1\<80% (under 5. percentile), FEV1/FVC\<75% (under 5. percentile), hospitalisation for asthma exacerbation in the last 12 months,
* Oral/sublingual/subcutaneous immunotherapy against other allergens in the first year/season of immunotherapy
* Eosinophilic gastroenteritis,
* Severe, recurrent episodes of anaphylaxis within the last 6 months,
* Chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
* Taking medication:
* oral, daily steroid therapy \>1 month in the past 12 months,
* At least two courses of oral steroid therapy (at least 7 days) within the last 12 months,
* One oral steroid therapy (min. 7 days) in the last 3 months,
* biological treatment,
* therapy with β-blockers, ACE-inhibitors, calcium channel inhibitors,
* Pregnancy,
* No consent to participate in the study,
* Lack of cooperation from the patient.
Well-controlled asthma, allergic rhinitis, atopic dermatitis are not considered exclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT07107451
Study Brief:
Protocol Section:
NCT07107451