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The effect of compound Lactobacillus on the reproductive tract of childbearing-aged women

The effect of compound Lactobacillus on the reproductive tract of childbearing-aged women: a prospective, randomized, double-blind controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82250363
Enrollment
116
Registered
2023-05-10
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with a vaginal pH greater than 4.5 Urological and Genital Diseases

Interventions

Current interventions as of 03/11/2025: Participants will be randomly allocated to the intervention group or the control group. The researcher will generate a random sequence with a random number ta

Sponsors

BGI Precision Nutrition (Shenzhen) Technology Co., Limited
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026