None listed
Conditions
Interventions
Dietary Supplement : Intervention group: Limosilactobacillus fermentum KBL674 400mg capsule once a day for 12 weeks
Placebo group: placebo 400mg capsule once a day for 12 week
Sponsors
weBiom
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women of age over 19 years of age and under 60 years of age 2) A person with a score of 4-6 on the Nugent Score. 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) Individuals currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and bile duct, renal and urological, neurological, musculoskeletal, psychiatric, infectious diseases, or malignancies (However, participation in the clinical trial may be allowed based on the investigator's judgment, considering the subject's condition). 2) Individuals who currently have or are being treated for vaginal or urinary tract infections as of Visit 1. 3) Individuals with vaginal bleeding, abnormal vaginal discharge, or urogenital abnormalities as of Visit 1. 4) Individuals who have administered systemic antibiotics, antimicrobials, steroids, immunosuppressants, or estrogen-based drugs (except those related to menopause) within 4 weeks prior to Visit 1 (However, topical formulations are excluded if used within 2 weeks prior to Visit 1). 5) Individuals who have consumed health-functional foods related to immune function improvement and vaginal health (e.g., red ginseng, mushroom extracts, chlorella, ginseng, shark liver oil containing alkoxyglycerols, aloe gel, oils containing gamma-linolenic acid, etc.) within 2 weeks prior to Visit 1. 6) Individuals who have administered or consumed probiotics, prebiotics, or lactic acid bacteria products (e.g., lactoferrin, UREX, Respecta®) continuously (four times per week or more) within 2 weeks prior to Visit 1. 7) Individuals who have used spermicides, feminine cleansers, vaginal washes, undergone mugwort steaming, or received acupuncture treatment for vaginal health within 1 week prior to Visit 1. 8) Individuals with symptoms of bowel movement difficulties (e.g., more than three times a day or fewer than twice a week) regularly. 9) Individuals with uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg measured after 10 minutes of rest). 10) Individuals with uncontrolled diabetes (fasting blood glucose level =180 mg/dL or random blood glucose level =250 mg/dL). 11) Individuals with AST (GOT) or ALT (GPT) levels exceeding three times the normal upper limit of the institution. 12) Individuals with creatinine levels exceeding twice the normal upper limit of the institution. 13) Individuals with TSH levels =0.1 µU/mL or =10 µU/mL. 14) Individuals sensitive or allergic to the food used in this clinical trial. 15) Pregnant or breastfeeding individuals, or those planning to become pregnant during the clinical trial period. 16) Individuals who participated in another interventional clinical trial (including human application studies) within 1 month (30 days) prior to Visit 1 or plan to participate in another interventional clinical trial (including human application studies) after the start of this clinical trial. 17) Individuals whom the investigator deems inappropriate for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nugent Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal pH;Vaginal microflora;Symptom Survey Assessment;Fecal microbiot | — |
Countries
Korea, Republic of
Contacts
Public ContactEunsil Lee
Soon Chun Hyang University Hospital Seoul
Outcome results
None listed