None listed
Conditions
Interventions
Dietary Supplement : Take test food (Ackermansia muciniphila EB-AMDK19 heat treatment culture dry matter, 1 capsule (500 mg)) or placebo food (500 mg/1 capsule) one capsule once a day, once a day with
Sponsors
Enterobiome Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person aged 19 or older and 65 or younger 2) A person who has had symptoms of atopic dermatitis intermittently or continuously for at least 6 months as of visit 1 3) A person with a Scoring of Atopic Dermatitis (SCORAD) score of 25 or more and 50 or less for Visit 1 and Visit 2 4) A person who has agreed to participate in the human body application test before the commencement of the human body application test and has completed a written consent form
Exclusion criteria
Exclusion criteria: 1) Persons currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, musculoskeletal system, mental, infectious disease and malignancy 2) Visiting 1 A person who has a skin disease that hinders the accurate evaluation of atopic dermatitis results, such as contact dermatitis, psoriasis, and skin infection (ohm, etc.) other than atopic dermatitis 3) Those with a history of skin disease or skin infections (bacteria, viruses, fungi) requiring systemic treatment within 2 weeks of visit 1 (except for localized water mantis with fewer than 20 lesions and viral warts) 4) A person who has a history of infectious bowel disease within two weeks based on visit 1 5) A person with a history of alcoholism or drug dependence 6) A person who has administered and applied the following drugs or received treatment on the basis of visit 1 A. A person who has administered antihistamines within two weeks based on visit 1 B. A person who has administered or ingested intestinal medicine, probiotics, prebiotics, and lactobacillus products continuously (more than four times a week) within two weeks of visit 1 C. Those who have applied topical steroids, topical antibiotics/antifungal drugs, and topical immunosuppressants within 2 weeks of visit 1 D. A person who has administered systemic antibiotics, steroids, or immunosuppressants within four weeks of visit 1 (except when inhaled steroids are used for asthma treatment) E. A person who has consumed herbal medicine and health functional foods to improve atopic dermatitis within four weeks of visiting 1 F. A person who has received phototherapy within 4 weeks of visit 1 7) Uncontrolled hypertension patients (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, and measurement criteria after stabilizing for 10 minutes in human body application test subjects) 8) Patients with uncontrolled diabetes (above 180 mg/dL of fasting blood sugar) 9) Those with a TSH of 0.1 uIU/mL or greater than 10 uIU/mL 10) A person whose creatinine is more than twice the upper limit of the institution's normal limit 11) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit 12) A person who is pregnant or is lactating or has a pregnancy plan during the main human body application test period 13) A person who is sensitive or allergic to food ingredients for this human application test 14) A person who has participated in other interventional clinical trials (including human-applied trials) within three months of the visit 1 or who plans to participate in other interventional clinical trials (including human-applied trials) after the start of this human-applied trial 15) A person who is deemed inappropriate by the tester for the human body application test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total SCORAD (Scoring of Atopic Dermatitis) Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective SCORAD Score;Subject SCORAD Score;EASI (Eczema Area and Severity Index);IGA (Investigator’s Global Assessment);POEM (Patient-Oriented Eczema Measure);DLQI (Dermatology Life Quality Index);Immunity-related Blood Indicators{IgE, Specific IgE(D1, D2), Total Eosinophil Count, LDH, TGF-a, TGF-ß1, TGF-ß2, TSLP, TARC, IL-4, IL-5, IL-6, IL-10, IL-13, IL-31};fecal flora | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Wook Son
Korea University Ansan Hospital
Outcome results
None listed