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A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Primary Purpose

Bacterial Vaginosis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Metronidazole vaginal suppositories
Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)
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 - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Aged 18 to 55 years old, with history of sexual activity,
  2. Amsel criterion for diagnosing BV
  3. Sign informed consent

Exclusion Criteria:

  1. History of systemic organic diseases or psychiatric diseases
  2. Planning for or during pregnancy, lactation, menstruation
  3. within 5 days of onset of the disease, any antibiotics has been used
  4. Long-term use of contraceptives or immunosuppressant
  5. Anaphylactic constitution or allergic to known ingredients of research drugs
  6. No same fixed partner (RSP) before and after treatment

Sites / Locations

  • Peking University Shenzhen HosptalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Metronidazole vaginal

Metronidazole vagianl and Probiotics(Umeta-mimi)

Arm Description

Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )

Metronidazole:Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) Probiotics:Oral Umeta-mimi( 5×109cfu per day,30 days）

Outcomes

Primary Outcome Measures

Cure rate of BV
Assessments with different Units of Measure:clinical symptoms such as itching or burning; "fishy" smell; homogeneous thin vaginal discharge;Nugent score; pH>4.5; clue cell.

Secondary Outcome Measures

Recurrence of BV
Nugent score
Recurrence of BV
Nugent score
Recurrence of BV
Nugent score

Full Information

First Posted
September 28, 2020
Last Updated
May 4, 2023
Sponsor
Peking University Shenzhen Hospital
Collaborators
BGI, China
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1. Study Identification

Unique Protocol Identification Number
NCT04771728
Brief Title
A Prospective, Randomized Controlled Study of the 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
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

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

5. Study Description

Brief Summary
The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis
Detailed Description
Studies have shown that oral Probiotics(Umeta-mimi) 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-mimi,30 days) with Metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis (BV) 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,14 days after treatment， the first month after treatment, 5-7 days after third menstruation after treatment and 5-7 days after sixth menstruation 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
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metronidazole vaginal
Arm Type
Active Comparator
Arm Description
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )
Arm Title
Metronidazole vagianl and Probiotics(Umeta-mimi)
Arm Type
Experimental
Arm Description
Metronidazole:Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) Probiotics:Oral Umeta-mimi( 5×109cfu per day,30 days）
Intervention Type
Drug
Intervention Name(s)
Metronidazole vaginal suppositories
Intervention Description
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )
Intervention Type
Drug
Intervention Name(s)
Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)
Other Intervention Name(s)
Metronidazole vaginal suppositories adn Probiotics(Umeta-mimi）
Intervention Description
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days）
Primary Outcome Measure Information:
Title
Cure rate of BV
Description
Assessments with different Units of Measure:clinical symptoms such as itching or burning; "fishy" smell; homogeneous thin vaginal discharge;Nugent score; pH>4.5; clue cell.
Time Frame
14 days after treatment
Secondary Outcome Measure Information:
Title
Recurrence of BV
Description
Nugent score
Time Frame
The first month after treatment
Title
Recurrence of BV
Description
Nugent score
Time Frame
5-7 days after third menstruation after treatment
Title
Recurrence of BV
Description
Nugent score
Time Frame
5-7 days after sixth menstruation after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 to 55 years old, with history of sexual activity, Amsel criterion for diagnosing BV Sign informed consent Exclusion Criteria: 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 No same fixed partner (RSP) before and after treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shangrong Fan, M.D.
Phone
86-755-83923333
Ext
5505
Email
fanshangrong@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yiheng Liang, M.D.
Phone
86-755-83923333
Ext
5505
Email
13510331823@163.com
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 Hosptal
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiheng Liang, M.D.
Phone
8675583923333
Ext
5505
Email
13510331823@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis

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