NCT01421615

Brief Summary

The purpose of this study is to examine the effect of lactobacillus preparation on Bacterial vaginosis (BV) in low-risk pregnant women and to evaluate the value of double courses for the patients with durative positive result. It is assumed that the living preparation of lactobacillus was beneficial for treatment of BV during pregnancy. The two-courses treatment can increase the response rate and improve pregnancy outcomes in the durative BV positive patients comparing with one-course one.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

11 months

First QC Date

August 8, 2011

Last Update Submit

August 22, 2011

Conditions

Bacterial Vaginosis

Keywords

Bacterial vaginosisProbioticsLactobacilliPregnancy outcomeRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Number of Participants who transformed to negative status of bacterial vaginosis

    The patients who were BV positive would receive treatment and be repeatedly evaluated BV status on the time of post-treatment 1 week, 28th gestational weeks, and before birth, respectively.The number of Participants who transformed to negative status of bacterial vaginosis will be recorded. The rates of bacterial vaginosis transformed to negative status will be calculated.

    6 months

Secondary Outcomes (3)

  • pregnancy outcome of mother

    6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)

  • pregnancy outcome of perinatal fetus

    6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)

  • Safety and tolerability

    6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)

Study Arms (3)

lotion

PLACEBO COMPARATOR

lotion:the patients in control group receive washing medicine and are followed up to the 4rd～7th days of postpartum.

Drug: Vaginal capsules of lactobacilli

lactobacilli capsule

EXPERIMENTAL
Drug: Vaginal capsules of lactobacilli

lactobacilli capsules

EXPERIMENTAL
Drug: Vaginal capsules of lactobacilli

Interventions

Vaginal capsules of lactobacilliDRUG

The patients in one-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they would NOT receive any treatment but would be followed up to the 4th-7th days of postpartum.

Also known as: Brand names: Dingjunsheng, Commodity code name: A246912309879, Approved by the state: S20030005
lactobacilli capsulelactobacilli capsuleslotion

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women at 16-18 gestational weeks with no history of premature labor or premature rupture of fetal membranes.

You may not qualify if:

  • who have menstrual disorder or forget the last menstrual period, and have no type-B ultrasonic result, so the gestational week is not clear.
  • Who have monilial vaginitis, trichomonas vaginitis, or sexual transmitted diseases.
  • who have severe medicochirurgic diseases.
  • multiple pregnancy.
  • anomalies of genital tract
  • fetal anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal and child care hospital in Panyu District

Guangzhou, Guangdong, 511400, China

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Yanfang Lee, Master

    The First Affiliated Hospital of Guangzhou University of TCM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanfang LEE

CONTACT

1392877712613928777126@139.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 23, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations

CN(1)