Skip to content

Vaginal microbiota restoration for bacterial vaginosis after treatment

Vaginal microbiota restoration for bacterial vaginosis treated with metronidazole and probiotic Lactobacillus intravaginally

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001484
Enrollment
Unknown
Registered
2011-08-25
Start date
2010-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Bacterial vaginosis

Interventions

Group A:Healthy Control
Group B:Bacterial Vaginosis without treatment
Group C:Bacterial Vaginosis treated with metronidazole
Group D:Bacterial Vaginosis treated with Lactobacillus DM8909

Sponsors

Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: The participants who met three or more of the following criteria were clinically diagnosed as BV: homogenous vaginal discharge, >20% clue cells on wet mount, elevated pH (>=4.5) of vaginal discharge, and release of a fishy amine odor upon addition of 10% potassium hydroxide solution to vaginal fluid ("whiff" test) . Then based on the criteria for BV assessment developed by Nugent et al. , participants with the Gram stain score of >=7 were finally confirmed as BV. Participants without these changes were defined as the healthy control group.

Exclusion criteria

Exclusion criteria: 1. <18 years of age; 2. Pregnancy; 3. Diabetes mellitus; 4. The use of antibiotics or vaginal antimicrobials (orally or by topical application in vulvar/vaginal area) in the previous month; 5. Menstruation; 6. Presence of an intrauterine device, vaginal intercourse within the latest 3 days, known active infection due to Chlamydia, yeast, N. gonorrhoeae, or T. vaginalis; 7. Clinically apparent herpes simplex infection, or defined diagnosed HPV, HSV-2, or HIV-1 infection.

Design outcomes

Primary

MeasureTime frame
Vaginal Bacterial Diversity;

Countries

China

Contacts

Public ContactCharlie Xiang
cxiang@zju.edu.cn+86 571 87236426

Outcome results

None listed

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