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 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT05965635
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 years and older;
* Negative Borrelia VlsE1/pepC10 ELISA.
Exclusion Criteria:
* Known history of tick bites;
* Positive Borrelia serology (VlsE1/PepC10 ELISA);
* Known history or current suspicion on any tick-borne disease;
* Chronic skin condition affecting the arm skin;
* Inability to maintain the dressing for any reason;
* Known immunodeficiency or autoimmune disease;
* Use of systemic immunomodulating drugs or chemotherapy, current or in the past;
* Chronic use of antibiotics;
* Unable to give informed consent or do not have a thorough command of the Dutch language;
* Refusal to participate in specimen collection and storage for future study related use;
* Pregnant or breastfeeding women;
* Not willing to use adequate contraception during the study period;
* Red meat allergy (both medically confirmed and self-reported);
* Use of investigational therapy and devices during the time of the study;
* Any other condition that, in the opinion of the investigator, would make the patient unsuitable for enrolment or could interfere with the patient participating in and completing the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05965635
Study Brief:
Protocol Section:
NCT05965635