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

Primary Purpose

Bacterial Vaginosis, Recurrence

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Metronidazole Oral

"Metronidazole" and "Lactobacillus"

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring Recurrence, Lactobacillus Vaginal Suppositories

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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）

Sites / Locations

Dept Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Metronidazole Oral

"Metronidazole" and "Lactobacillus"

Arm Description

Metronidazole Oral

"Metronidazole" and "Lactobacillus"

Outcomes

Primary Outcome Measures

Cure rate of BV

Nugent score

Secondary Outcome Measures

Recurrence of BV

Nugent score

Recurrence of BV

Nugent score

Full Information

NCT ID

NCT03099408

First Posted

March 28, 2017

Last Updated

January 28, 2021

Sponsor

Peking University Shenzhen Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03099408

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

December 30, 2020 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Shenzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Vaginosis, Recurrence

Keywords

Recurrence, Lactobacillus Vaginal Suppositories

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metronidazole Oral

Arm Type

Active Comparator

Arm Description

Metronidazole Oral

Arm Title

"Metronidazole" and "Lactobacillus"

Arm Type

Active Comparator

Arm Description

"Metronidazole" and "Lactobacillus"

Intervention Type

Drug

Intervention Name(s)

Metronidazole Oral

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

"Metronidazole" and "Lactobacillus"

Intervention Description

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 Outcome Measure Information:

Title

Cure rate of BV

Description

Nugent score

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Recurrence of BV

Description

Nugent score

Time Frame

12 weeks

Title

Recurrence of BV

Description

Nugent score

Time Frame

24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

48 Years

Accepts Healthy Volunteers

Eligibility Criteria

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）

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shangrong Fan, M.D.

Organizational Affiliation

Peking University Shenzhen Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Salvatore Giovanni Vitale, M.D.

Organizational Affiliation

Department of Human Pathology in Adulthood and Childhood, University of Messina (Italy)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept Obstetrics and Gynecology

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518036

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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