None listed
Conditions
Interventions
Dietary Supplement : This clinical trial is randomly assigned to test group I (KBL693) or test group II (KBL697) or control group and is taken twice a day (2g/pouch) once a day. (Lactobacillus crispat
Sponsors
Kobiolabs
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person who agrees to participate in this clinical trial and has voluntarily signed a Informed consent form with his/her parents (or legal representative). 2) A person who are over 2 years of age and under 16 years of age. 3) A person who have intermittent or persistent atopic dermatitis symptoms for more than six months 4) A person whose SCORAD score is 25 to 50 points (mild-modelate) in Visit 1 and 2. 5) A person diagnosed with atopic dermatitis according to the diagnosis criteria of Hanifin and Rajka.
Exclusion criteria
Exclusion criteria: 1) A person who has severe skin diseases and systemic diseases other than atopic dermatitis. 2) A person who has administered systemic antibiotics, systemic corticosteroids, and antihistamines in relation to atopic dermatitis within four weeks of the start of the clinical trial. 3) A person who administers systemic immunosuppressants within 12 weeks of the clinical trial. 4) A person who administers medicine, herbal medicine, and health functional foods to improve atopic dermatitis within one week of the start of the clinical trial. 5) A person who has taken probiotics health functional foods, consistently fermented milk, and digestive (at least four times a week) within one week of the start of the clinical trial. 6) A person who has received phototherapy within four weeks of the start of the clinical trial. 7) A person who has plans to participate in other clinical trials during clinical trial(excluding observational research). 8) A person who participated in other clinical trials within four weeks of the start of the clinical trial(excluding observational research). 9) A person who is deemed unfit for the clinical trial by investigator. 10) A person who has an anamnesis of hypersensitivity to probiotics and pseudo-sequences.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scoring atopic dermatitis total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Scoring atopic dermatitis objective score;Scoring atopic dermatitis subjective score;IGA(Investigator’s Global Assessment);Eosinophil, ECP, Total IgE, cytokine(IL-4, IL-5, IL-10, IL-13, IL-17, IL-22, IFN-?, TGF-ß, TNF-a, CCL11(Eotaxin-1), CCL17(TARC), CCL22(MDC), CCL26(Eotaxin-3), CCL27(CTACK));Skin pH, Transepidermal water loss, moisture content;Use ratio and usage of local steroids;intestinal mycelium variation | — |
Countries
Korea, Republic of
Contacts
Public ContactHEERAN KIM
Samsung Medical Center
Outcome results
None listed