None listed
Conditions
Interventions
Dietary Supplement : Intervention group: Lactobacillus acidophilus YT1 280mg capsule once a day for 12 weeks
Placebo group: placebo 280mg capsule once a day for 12 weeks
Sponsors
Huons
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women of childbearing age over 19 years of age and under 50 years of age 2) A person with a score of 4-6 on the Nugent core. 3) A person who agrees to participate in the human application test before the human application test begins and has prepared the written consent form.
Exclusion criteria
Exclusion criteria: 1) Those who are currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal tract/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease and malignant tumor (however, considering the condition of the human subject You can participate in the test at the discretion of the tester.) 2) The subjects who treated for vaginal or urinary tract infection as of Visit 1 (e.g., candidiasis, trichomonas infection, gonorrhea, chlamydial infection, etc.) 3) The subjects with vaginal bleeding, abnormal vaginal secretion, or urinary system abnormality as of the standard of Visit1 4) The subjects who has been given ystemic antibiotics, antimicrobial agents, steroids, immunosuppressants, estrogen-based drugs (pneumonia-related drugs are allowed) within 4 weeks of visit 1 (but those who used them within 2 weeks of visit 1 cannot participate in the test) 5) The subjects who has consumed health functional foods related to improving immune function and vaginal health (including red ginseng, yellow corvina mushroom extract, chlorella, ginseng, and alkoxyglycerol-containing shark liver oil, aloe gel, and gamma-linolenic acid) within 2 weeks of visiting 1 6)The subjects who has administered probiotics and prebiotics within two weeks based on visit 1 (UREX, Respecta®, etc.) or has continuously administered or ingested fermented milk and lactobacillus products at least four times a week 7) The subjects who has received salivary treatment for sedimentation, women's cleansers, vaginal sanitizers, left fumigation, and vaginal health within one week of visit 1 8) The subjects with unregulated hypertension (measuring standard after 10 minutes stabilization of the person subject to human application test) (above 160mmHg of blood pressure in the retractor or 90mmHg of blood pressure in the retractor). 9) Unregulated diabetics (HbA1c > 7.0 %) 10) The subjects who AST (GOT) or ALT (GPT) is at least three times the normal limit of the testing agency 11) The subjects who eGFR is less than 60 mL/min/1.73 m2 12) The subjects who TSH is less than 0.1 µU/mL or greater than 10 µU/ml 13) The subjects who are sensitive or allergic to the ingredients of this human-applied test food 14) The subjects who are pregnant, breast-feeding, or planning to conceive within three months. 15) If the daily alcohol intake is more than 20g [Female = 20g/day (according to WHO's daily alcohol intake standards)] 16) Excessive smokers (=20 pieces/day) 17)The subjects who has participated in another interventional clinical trial (including a human application test) within one month of the commencement of this human application test or who has a plan to participate in another interventional clinical trial (including a human application test) after the commencement of this human application test. 18) The subjects who is deemed inappropriate by the human application test testers for this human application test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nugent Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal pH;Vaginal microflora;Symptom Survey Assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactSungTaek Park
Hallym University Medical Center-Kangnam
Outcome results
None listed