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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT07184905
Eligibility Criteria:
Inclusion Criteria :
* 1\. Meets 2020 WHO BMI classification:
* a. Normal weight (18.5-24.9 kg/m²)
* b. Overweight (25-29.9 kg/m²)
* c. Obesity (≥30 kg/m²)
* 2\. Presence of skin barrier impairment (e.g., dryness, erythema, desquamation, or itching)
* 3\. Age 18-40 years
* 4\. Generally good health (no active systemic diseases)
* 5\. Able and willing to provide written informed consent
* 6\. No use of oral/topical medications or probiotics within 6 months prior
* 7\. No active skin disease or traumatic skin lesions
Exclusion Criteria :
* 1\. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
* 2\. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
* 3\. Severe medical conditions:
* a. Cardiopulmonary disease (NYHA class III/IV)
* b. Uncontrolled diabetes (HbA1c \>9%)
* c. Autoimmune disorders
* 4\. Pregnant or breastfeeding women
* 5\. Any condition that may interfere with protocol compliance (per investigator judgement), including:
* a. Inability to understand study procedures
* b. History of poor clinical trial adherence
* 6\. Concurrent participation in other interventional trials
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT07184905
Study Brief:
Protocol Section:
NCT07184905