None listed
Conditions
Interventions
Others(health functional foods) : Sticks (2 g/package) containing the powder of the test food (BCL-2, B. longum RAPO and L. plantarum LRCC5264 complex, 1.0 × 109 CFU/day) or the control food (Placebo)
Sponsors
Korea University Ansan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Persons more than 2 years of age but less than 65 years of age 2) Those whose atopic dermatitis symptoms persisted for at least 6 months as of visit 1 3) Those whose SCORAD (SCORing Atopic Dermatitis) score at Visit 1 and Visit 2 is 20 to 50 (Mild to Moderate) 4) A person who agrees to participate in this human application test before the human application test begins, and the subject or legal representative completes a written consent form (Informed Consent Form)
Exclusion criteria
Exclusion criteria: 1) Those currently receiving treatment for severe cardiovascular, respiratory, gastrointestinal/liver and biliary tract, kidney and urinary, nervous, musculoskeletal, psychiatric, and infectious diseases. 2) In addition to atopic dermatitis, people with skin diseases that impede accurate evaluation of atopic dermatitis results, such as irritant contact dermatitis, allergic contact dermatitis, infection (scabies, etc.), or psoriasis. 3) Those with skin or skin infections (bacteria, viruses, fungi) that require systemic treatment within 2 weeks of visit 1 (excluding localized molluscs with less than 20 lesions and viral warts) 4) People with systemic diseases such as immunodeficiency, autoimmune disease, cancer, etc. 5) Those who received the following drugs or treatment before visit 1 A. Those who have administered systemic antibiotics, steroids, or immunosuppressants within 4 weeks of visit 1 B. Those who consumed herbal medicine, health functional foods, and probiotic products related to atopic dermatitis within 4 weeks of visit 1 C. Those who received phototherapy within 4 weeks of visit 1 D. Those who have received treatment with topical steroids, topical immunosuppressants, oral antihistamines, and topical antibiotics/antifungals within 2 weeks of visit 1 (excluding cases where inhaled steroids are used to treat asthma) 6) Those with a history of infectious bowel disease within 2 weeks of visit 1 7) Those who are pregnant, lactating, or planning to become pregnant during this human application test period 8) Those who have participated in other interventional clinical trials (including human trials) within 3 months of the start of this human trial, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial 9) Those who are sensitive or allergic to the food ingredients for this human application test 10) A person who is deemed unsuitable by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total SCORAD(Scoring of Atopic Dermatitis) Index | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective SCORAD(Scoring of Atopic Dermatitis) Index;Subjective SCORAD(Scoring of Atopic Dermatitis) Index;IGA(Investigator's Global Assessment);Pruritus NRS(Numeral Rating Scale);Total IgE(Immunoglobulin E), Specific IgE(D1, D2), Total Eosinophil Count;Cytokine: TNF-a, IFN-?, IL-1ß, IL-4, IL-6, IL-10, IL-17 ;PGA(Patient's Global Assessment);Rate and amount of topical steroid use;Fecal flora, SCFA(Short Chain Fatty Acid) | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Wook Son
Korea University Ansan Hospital
Outcome results
None listed