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Efficacy and safety of probiotics in the treatment of bacterial vaginitis

Efficacy and safety of probiotics in the treatment of bacterial vaginitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097419
Enrollment
Unknown
Registered
2025-02-19
Start date
2024-02-18
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

bacterial vaginosis (BV)

Interventions

Healthy Controls:Healthy control group, women with normal medical examination
Antibiotic therapys:Conventional antibiotic treatment group, metronidazole vaginal suppository, vaginal application 1 time/day* 7 days
Probiotic interventions:Probiotic treatment group, vaginal probiotic treatment, use as directed* for 7 days
Probiotics + antibiotic therapys:In the probiotic + antibiotic treatment group, antibiotic treatment was followed by 12 hours of combined probiotic treatment for 7 days

Sponsors

The Ninth Hospital of Nanchang
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18-55 years, history of sexual intercourse, meeting the diagnostic criteria for BV; 2. No malignant tumour of the reproductive tract, excluding CIN3, no history of hysterectomy and pelvic radiotherapy; 3. No antimicrobial treatment within 3 months, no sexual intercourse for 3 days before the examination, no vaginal douching and no medication.

Exclusion criteria

Exclusion criteria: 1. Patients with gonorrhea, genital herpes, and genital warts; 2. Individuals with reproductive system and other systemic diseases; 3. Pregnancy; 4. Breastfeeding women; Patients who have undergone vaginal flushing, used spermicides, and sanitary tampons within 7 days prior to treatment. 6. Abnormal HPV and TCT testing; 7. Use systemic medications; 8. Use probiotics (orally or vaginally); 9. Use traditional Chinese medicine or homeopathic medicine; 10. Acute diseases; 11. History of tumor; 12. Positive serological tests for HIV, hepatitis C, hepatitis B, or syphilis. 13. History of gastrointestinal diseases, autoimmune diseases and immunomodulatory therapy, chronic pain and neuropsychiatric disorders, obesity (BMI>30).

Design outcomes

Primary

MeasureTime frame
Clinical outcomes after treatment;

Secondary

MeasureTime frame
Pathogenetic efficacy after treatment;Changes in vaginal flora after treatment;

Countries

China

Contacts

Public ContactXia He

The Ninth Hospital of Nanchang

hx794622@163.com+86 151 7003 7946

Outcome results

None listed

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