Participants shall be aged >=18 and <=60 years of either gender, and be healthy individuals with dry skin and impaired skin barrier function.
Conditions
Interventions
Test group:Oral administration of Bifidobacterium longum subsp. longum BLG-19, one sachet once daily. Take directly or dissolve in 100 mL warm water (water temperature <= 40°C) for oral intake.
Placebo control group:Oral administration of equivalent maltodextrin placebo, once daily, 1 sachet each time, taken directly or dissolved in 100 mL warm water (water temperature =40 ?).
Sponsors
Shanghai Fengxian District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 and <= 60 years old; gender unrestricted; 2.Subjects with at least one self-perceived symptom of impaired skin barrier function, including dryness, desquamation, erythema, etc.; 3.No severe lesions, obvious scars, abnormal pigmentation or other interfering skin conditions on the facial test area; 4.Able to fully cooperate with the trial and maintain regular living habits throughout the test period; 5.Have not participated in any other human research projects involving the facial test area within the past one month, including human safety and efficacy evaluations or interventional studies of cosmetics, pharmaceuticals, medical devices, functional raw materials and related products; and shall not concurrently participate in any above-mentioned types of studies during this trial; 6.Able to understand the trial procedures, voluntarily participate in the study and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects with a severe allergy history or previous skin disease history; 2.Subjects complicated with severe diseases involving the heart, liver, kidney, hematopoietic system and other organs; 3.Subjects with mental illness or severe endocrine disorders (uncontrolled chronic systemic diseases such as diabetes and hypertension); 4.Subjects who have taken long-term or recent medications that may mask adverse reactions or interfere with trial results, including topical functional skin care products, anti-inflammatory drugs, antioxidant preparations, intestinal regulating agents, oral beauty foods for whitening and anti-aging, various probiotic products, etc.; 5.Subjects suffering from skin diseases, chronic metabolic diseases, immunodeficiency diseases or other conditions that may affect test results and render them ineligible for this trial; 6.Subjects with frequent sun exposure on the test area or outdoor workers; 7.Any other conditions deemed inappropriate for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transepidermal Water Loss (TEWL);Stratum Corneum Hydration;Facial image acquisition and analysis of a* value and proportion of red area; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin gloss value;Skin elasticity;Facial Image Acquisition and Analysis of L* Value and ITA°;16S sequencing;Blood Biochemical Tests (Albumin, Alanine Aminotransferase, Aspartate Aminotransferase, Total Bilirubin, Direct Bilirubin, Serum Creatinine, Blood Urea Nitrogen, Uric Acid);TNF-a?IL-6?IL-1ß?MDA?SOD?GSH-Px?8-OHdG?Cortisol?Serotonin?MMP-1?Type I procollagen;Vital signs, mental status, sleep, diet, defecation, urination and other major clinical symptoms; | — |
Countries
China
Contacts
Public ContactZhu Haiying
Shanghai Fengxian District Central Hospital
Outcome results
None listed