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Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
"Probiotics" and "Metronidazole"
Metronidazole Vaginal
Sponsored by
Peking University Shenzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18 to 65 years old, with history of sexual activity, premenopausal women；
  2. Nugent Score ≥ 7 for diagnosing BV；
  3. Sign informed consent.

Exclusion Criteria:

  1. mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
  2. History of systemic organic diseases or psychiatric diseases;
  3. Planning for or during pregnancy, lactation, menstruation;
  4. within 5 days of onset of the disease, any antibiotics has been used;
  5. Long-term use of contraceptives or immunosuppressant;
  6. Anaphylactic constitution or allergic to known ingredients of research drugs.

Sites / Locations

  • Peking University Shenzhen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Probiotics and Metronidazole

Metronidazole vaginal

Arm Description

Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days)

Metronidazole vaginal suppositories(1 suppositories,qd,7 days )

Outcomes

Primary Outcome Measures

Number of Participants With Related Clinical Signs or Symptoms at Baseline
Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated.
Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up
Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated.
Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up
Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the 30-day follow-up data) were calculated.
Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2019
Last Updated
June 17, 2021
Sponsor
Peking University Shenzhen Hospital
Collaborators
BGI, China
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1. Study Identification

Unique Protocol Identification Number
NCT03894813
Brief Title
Probiotics as Adjuvant Treatment for Bacterial Vaginosis
Official Title
Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 26, 2019 (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
Collaborators
BGI, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal suppositories(7 days) is better than using metronidazole vaginal suppositories only in preventing the recurrence of bacterial vaginosis (BV).
Detailed Description
Studies have shown that oral probiotics can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days) with metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase, the first month after treatment, the third month after treatment and the sixth month after treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics and Metronidazole
Arm Type
Experimental
Arm Description
Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days)
Arm Title
Metronidazole vaginal
Arm Type
Active Comparator
Arm Description
Metronidazole vaginal suppositories(1 suppositories,qd,7 days )
Intervention Type
Drug
Intervention Name(s)
"Probiotics" and "Metronidazole"
Other Intervention Name(s)
Umeta-Miyue, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14 and Metronidazole Suppositories
Intervention Description
Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)
Intervention Type
Drug
Intervention Name(s)
Metronidazole Vaginal
Other Intervention Name(s)
Metronidazole Suppositories
Intervention Description
Metronidazole Suppositories,qd, 7 days
Primary Outcome Measure Information:
Title
Number of Participants With Related Clinical Signs or Symptoms at Baseline
Description
Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated.
Time Frame
1 day before starting treatment
Title
Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up
Description
Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated.
Time Frame
the 30th day after starting treatment
Title
Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up
Description
Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the 30-day follow-up data) were calculated.
Time Frame
the 90th day after starting treatment
Title
Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up
Description
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
Time Frame
the 30th day after starting treatment
Title
Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up
Description
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
Time Frame
the 90th day after starting treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 to 65 years old, with history of sexual activity, premenopausal women； Nugent Score ≥ 7 for diagnosing BV； Sign informed consent. Exclusion Criteria: mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis; History of systemic organic diseases or psychiatric diseases; Planning for or during pregnancy, lactation, menstruation; within 5 days of onset of the disease, any antibiotics has been used; Long-term use of contraceptives or immunosuppressant; Anaphylactic constitution or allergic to known ingredients of research drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruifang Wu, M.D.
Organizational Affiliation
Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotics as Adjuvant Treatment for Bacterial Vaginosis

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