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Multi - center clinical study on the effect of probiotics on female bacterial vaginopathy

Multi - center clinical study on the effect of probiotics on female bacterial vaginopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014876
Enrollment
Unknown
Registered
2018-02-12
Start date
2018-02-26
Completion date
Unknown
Last updated
2018-02-19

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

Conditions

bacterial vaginosis

Interventions

Study Group:Treated with probiotics
Control Group: Treated with metronidazole gel

Sponsors

Beijing Chaoyang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Women aged 18-60 years with a history of sexual (2) Participate in the study voluntarily (3) Pregnant women of childbearing age were negative in urine pregnancy test and could insist on contraception during the trial period; (4) Patients meeting with the diagnostic criteria of bacterial vaginosis (Amsel standard).

Exclusion criteria

Exclusion criteria: 1) Pruritus and pain caused by Behcet's disease, diabetes mellitus; vulvovaginitis caused by pelvic inflammation; 2) Trichomoniasis vaginitis, fungal vaginitis, gonococcus, chlamydia trachomatis, vaginitis and pelvic inflammation caused by herpes simplex virus or human stinger virus; 3) Serious primary diseases such as severe cardiovascular and cerebrovascular diseases, history of abnormal liver and kidney function, hematopoietic system, etc.; 4) Pregnant, breast-feeding, and women have pregnancy plan; 5) Long-term use of antimicrobial agents; 6) Patients who need to be treated with other antifungal drugs; 7) Allergic constitution or known allergic to metronidazole; 8) Patients treated with HRT (hormone use); 9) Patients who received antifungal and microbiological therapy (systemic or intravaginal) within 2 weeks of treatment in this study; 10) Suspected malignant neoplasms or other serious diseases; 11) Patients with severe immunodeficiency or immunosuppressant use; 12) Severe liver and kidney diseases, or the level of Alt or Cr in blood is higher than the upper of normal range; 13) Patients who need treatment for cervical intraepithelial neoplasia and acute cervicitis; 14) Menstruating women; 15) Persons known to have a history of drug and alcohol abuse; 16) The researchers found that they were not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Leucorrhea smear microscopic examination;Nugent Score;

Countries

China

Contacts

Public ContactQu Hong

Beijing Chao-yang Hospital, Capital Medical University

qhquhong1980@163.com+86 18910093231

Outcome results

None listed

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