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A prospective randomized controlled trial of Lactobacillus intervention in bacterial vaginosis

A prospective randomized controlled trial of Lactobacillus intervention in bacterial vaginosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107215
Enrollment
Unknown
Registered
2025-08-06
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Bacterial vaginosis

Interventions

Intervention group:Lactobacillus intervention
Control group:Placebo

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Premenopausal women aged 18 to 45 years; 2. No recent use of hormones, antibiotics, or vaginal drugs (no vaginal irrigation within 5 days and no vaginal sex within 48 hours); 3. Meets at least three of Amsel's four criteria (i.e., thin, white or yellow, uniform discharge; 20% of the clue cells were > in microscopic examination; vaginal fluid pH >4.5; fishy odor is released when 10% potassium hydroxide is added to vaginal samples); Nugent Score (4-10) 4. Those who sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnancy status; 2. Patients suffering from AIDS, syphilis, hepatitis and other infectious diseases; 3. Negative swab positive molecular test for gonorrhea, chlamydia and trichomoniasis infection; 4. Urine sample test suggests urinary tract infection; 5. Patients who have been taking hormonal drugs and immunosuppressant drugs for a long time; 6. Patients who need to take antibiotics during the chronic inflammation study; 7. Patients with severe vulvar and vaginal itching symptoms; 8. Not signed informed consent; 9. Inability to follow up regularly; 10. Inability to use Lactobacillus vaginalis preparations continuously for 1 week after the end of metronidazole treatment; 11. Other conditions that the investigator deems unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Amsel criteria;Nugent score;

Countries

China

Contacts

Public ContactLan Zhu

Peking Union Medical College Hospital

zhu_julie@vip.sina.com+86 13911714696

Outcome results

None listed

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