None listed
Conditions
Interventions
Dietary Supplement : Consume 1 chewable tablet (1,500 mg) of either the test product (containing L. plantarum LRCC5195) or the control product once daily.
Sponsors
Lotte Chilsung Beverage
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Children aged 3 to less than 11 years. 2) Subjects with a history of atopic dermatitis symptoms persisting for at least 6 months as of Visit 1. 3) Subjects with a SCORAD (SCORing Atopic Dermatitis) index ranging from 20 to 50 (mild to moderate severity) at both Visit 1 and Visit 2. 4) Subjects and their parents (or legal guardians) who voluntarily agree to participate in the study and sign the Informed Consent Form (ICF) prior to the initiation of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects currently under treatment for severe cardiovascular, respiratory, gastrointestinal/hepatobiliary, renal/urinary, neurological, musculoskeletal, psychiatric, or infectious diseases. 2. Subjects with skin diseases other than atopic dermatitis that may interfere with the accurate evaluation of study results, such as irritant contact dermatitis, allergic contact dermatitis, infections (e.g., scabies), or psoriasis. 3. Subjects with a skin infection (bacterial, viral, or fungal) requiring systemic treatment within 2 weeks prior to Visit 1 (excluding localized molluscum contagiosum with fewer than 20 lesions and viral warts). 4. Subjects with systemic diseases such as immunodeficiency, autoimmune disorders, or cancer. 5. Subjects who have received the following medications or treatments prior to Visit 1: A. Use of systemic antibiotics, steroids, or immunosuppressants within 4 weeks prior to Visit 1. B. Consumption of medicines, herbal medicines, health functional foods, or probiotic products related to atopic dermatitis within 4 weeks prior to Visit 1. C. Received phototherapy within 4 weeks prior to Visit 1. D. Use of topical steroids, topical immunosuppressants, oral antihistamines, or topical antibiotics/antifungals within 2 weeks prior to Visit 1 (excluding inhaled steroids for asthma treatment). 6. Subjects with a history of infectious gastrointestinal disease within 2 weeks prior to Visit 1. 7. Subjects with known sensitivity or allergy to the ingredients of the investigational product. 8. Subjects who have participated in any other interventional clinical trial (including human application studies) within 3 months prior to the start of this study, or who plan to participate in another interventional clinical trial during the study period. 9. Subjects considered unsuitable for participation by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SCORing Atopic Dermatitis Index | — |
Secondary
| Measure | Time frame |
|---|---|
| SCORing Atopic Dermatitis Objective Score;SCORing Atopic Dermatitis Subjective Score;Investigator's Global Assessment;Pruritus Numeral Rating Scale;Total Immunoglobulin E, Total Eosinophil Count;Tumor Necrosis Factor-alpha, Thymus and Activation-Regulated Chemokine, Eotaxin, Interleukin-4, Interleukin-13, Interleukin-17, Interleukin-22;Patient's Global Assessment;Usage Rate and Amount of Topical Corticosteroids;Fecal Microbiota, Short-Chain Fatty Acids | — |
Countries
Korea, Republic of
Contacts
Public ContactKui Young Park
Chung-Ang Univerisity Hospital
Outcome results
None listed