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OpenTrials
Completed

NCT Number: NCT03099408

Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent Recurrence of Bacterial Vaginosis

We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis

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Key information

About this study

Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV).

Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates.

Based on currently national guidelines by using oral metronidazole 400 BID for 7 days, a high recurrence rate of BV were reported.

We hypothesize that the Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women be at least 18 years of age
  • Have symptoms of vaginal odor and or/discharge
  • Meet the clinical (Amsel) criteria for BV
  • Willing to participate in research

Exclusion criteria

  • Presence of another vaginal infection or STD
  • Allergy to metronidazole
  • Pregnant or nursing
  • Use of oral or intravaginal antibiotics within the past 2 weeks
  • HIV or other chronic disease
  • Inability to keep return appointments
  • Contraindications for Lactobacillus Vaginal Suppositories(those without sexual history)

Treatment and study plan

Metronidazole Oral

Drug

Oral metronidazole 400 mg BID for 7 days at first month.

"Metronidazole" and "Lactobacillus"

Drug

Oral metronidazole metronidazole 400 mg BID for 7 days at first month and Lactobacillus vaginal suppositories for 10 days at first month,second month and third month.

Primary outcomes

  1. Cure rate of BV

    Time frame: 4 weeks

    Nugent score

Secondary outcomes

  1. Recurrence of BV

    Time frame: 12 weeks

    Nugent score

  2. Recurrence of BV

    Time frame: 24 weeks

    Nugent score

Sponsors and collaborators

Lead sponsor

Peking University Shenzhen Hospital

Other

Registry information

Official study title

A Pilot Study of Efficacy and Safety of Oral Metronidazole Versus Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent the Recurrence of Bacterial Vaginosis

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2017
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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