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Vaginal Microbiota Transplant

NCT04046900 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-07-18

No results posted yet for this study

Summary

This is a randomized trial of vaginal microbiome transplant vs. saline placebo to restore a Lactobacillus dominant vaginal microbial community in women with recurrent bacterial vaginosis.

Conditions

  • Recurrent Bacterial Vaginosis

Interventions

BIOLOGICAL

Vaginal microbiome transplant

Vaginal fluid from healthy donors

DRUG

Oral Metronidazole

500mg oral metronidazole twice daily for 7 days

OTHER

Sterile saline

700 uL of sterile saline placed in the vagina as a placebo intervention.

Sponsors & Collaborators

  • Douglas Kwon

    lead OTHER

Principal Investigators

  • Doug Kwon, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046900 on ClinicalTrials.gov