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:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT07051902
Eligibility Criteria:
Inclusion Criteria (Study Group):
* Aged ≥3 years.
* Able to provide informed consent (for ages ≥18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \<18 years).
* Positive Screening questionnaire for asthma or eczema.
* Diagnosed with atopic dermatitis or asthma via physician diagnosis and criteria as follows:
* Clinical diagnosis of atopic disease, as defined by Hanifin and Rajka criteria, that has been present for ≥3 months before the screening visit.
Inclusion Criteria (Healthy Volunteers):
* Aged ≥3 years.
* Able to provide informed consent (for ages ≥18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \<18 years).
* Negative Screening questionnaire for asthma and eczema.
* In good general health as evidenced by medical history and not diagnosed with atopic dermatitis or asthma via physician diagnosis.
* Failure to meet Hanifin and Rajka criteria and \<3 on GINA guidelines for asthma diagnosis.
* No self-reported history of food allergy.
Exclusion Criteria:
* Use of antibiotics in the 3 months prior to screening.
* Current pregnancy or lactation (determined by self-report).
* Treatment with an investigational drug within 12 months prior to screening.
* Current smoker or tobacco use within 4 months prior to screening.
* Current skin infections other than atopic dermatitis (e.g., scabies).
* Active diarrhea as defined by three or more loose stools per day (Bristol stool scale score of 6 or 7).
* Presence of current bacterial, viral, or fungal infection, with the exception of isolated onchomycosis, which is not exclusionary.
* Any other condition or factor that the investigator determines may significantly influence the results of testing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT07051902
Study Brief:
Protocol Section:
NCT07051902