NCT06263465

Brief Summary

The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 18, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

January 23, 2024

Last Update Submit

May 13, 2024

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • BV recurrence rate

    Primary Outcome Measure

    month 12

Secondary Outcomes (2)

  • vaginal secretions 16s rRNA gene sequencing

    2 weeks，month 1，month 3、month 6、month 12

  • BV recurrence rate

    2 weeks，month 1，month 3、month 6

Study Arms (2)

Lactobacillus cispatus

EXPERIMENTAL

10\^9 cfu,5 days

Other: Lactobacillus cispatus

Placebo

PLACEBO COMPARATOR

0 cfu,5 days

Other: placebo

Interventions

Lactobacillus cispatusOTHER

10\^9 cfu,5 days

Lactobacillus cispatus
placeboOTHER

0 cfu,5 days

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. History of sexual behaviour 2.18-55 years old 3. Women were diagnosed as bacterial vaginosis

You may not qualify if:

  • During pregnancy, or within 8 weeks after delivery;
  • presence of systemic diseases (such as SLE, malignant tumors, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhuhai People'S Hospital

Zhuhai, Guangdong, 519050, 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

  • Hongwei Zhou, Professor

    Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muxuan Chen, Doctor

CONTACT

+8613580561916muxuanchen@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 16, 2024

Study Start

March 18, 2024

Primary Completion

July 1, 2025

Study Completion

December 31, 2025

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

CN(1)