Women with a vaginal pH greater than 4.5 Urological and Genital Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-menopausal women aged 18-55 years 2. Self-test vaginal pH value over 4.5 at 2 or 3 days after menstruation 3. Willing to stop consuming probiotic supplements (yoghurt excluded) within 1 week of enrollment and to stop consuming fiber supplements during the intervention 4. Sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Menopause 2. Pregnancy, latency, and prepared pregnancy 3. Systemic antibiotic exposure 1 week before enrollment 4. Diagnosed with the systematic disease 5. History of gastrointestinal surgery or cancer 6. Diagnosed with the reproductive disease 7. Atopic, or allergy to the known ingredient of the product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 03/11/2025: Vaginal pH values are measured using a self-testing vaginal pH kit at baseline, 7, 14, 21, and at the intervention of one menstrual cycle. _____ Previous primary outcome measures: Vaginal pH values are measured using a self-testing vaginal pH kit at baseline, 7, 14, 21, and 2-3 days after the next menstruation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 03/11/2025: 1. The relative abundance and increase of the three strains in virginal discharge will be measured using vaginal discharge collection kits at baseline, day 14, and at the intervention of one menstrual cycle. 2. The abundance and increase of Lactobacillus in virginal discharge will be measured using vaginal discharge collection kits at baseline, day 14, and at the intervention of one menstrual cycle. 3. The detected rate and abundance of the virginal particular pathogen will be measured using vaginal discharge collection kits at baseline, day 14, and at the intervention of one menstrual cycle. 4. The increase and relative abundance of the three strains in feces will be measured using fecal collection kits at baseline, day 14, and at the intervention of one menstrual cycle. 5. The relative abundance and increase of Lactobacillus in feces will be measured using fecal collection kits at baseline,day 14, and at the intervention of one menstrual cycle. 6. The comparison of alpha-diversity of the fecal microbiota will be measured using fecal collection kits at baseline, day 14, and at the intervention of one menstrual cycle. 7. The increase of the relative abundance of short-chain fatty acid producing bacteria in gut microbiota will be measured using fecal collection kits at baseline, day 14, and at the intervention of one menstrual cycle. _____ Previous secondary outcome measures: 1. The relative abundance and increase of the three strains in virginal discharge will be measured using vaginal discharge collection kits at baseline, 7, and 2-3 days after the next menstruation 2. The abundance and increase of Lactobacillus in virginal discharge will be measured using vaginal discharge collection kits at baseline, 7, and 2-3 days after the next menstruation 3. The detected rate and abundance of the virginal particular pathogen will be measured using vaginal discharge collection kits at baseline, 7, and 2-3 days after th | — |
Countries
China