Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 50Years
FEMALE
NCT04046900

Vaginal Microbiota Transplant

Led by Douglas Kwon · Updated on 2025-07-18

62

Participants Needed

1

Research Sites

283 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Vaginal Microbiota Transplant

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Premenopausal women aged 18 to 50 years
  • Abnormal Nugent score greater than 3
  • History of recurrent bacterial vaginosis with 3 or more documented episodes in the past 12 months
  • Agreement to use effective contraception if sexually active and able to become pregnant, including condoms, intrauterine device, or hormonal contraceptives
Not Eligible

You will not qualify if you...

  • History of significant vaginal, cervical, or uterine disease such as cancer, prior hysterectomy, or high grade cervical dysplasia (CIN III)
  • Diagnosed cervicovaginal infection other than bacterial vaginosis within 30 days prior to the procedure
  • Allergy to metronidazole
  • Use of investigational therapies or vaccines within 90 days prior to study entry
  • Use of immunomodulatory agents or systemic steroids within 30 days prior to enrollment
  • History of coronary artery disease, myocardial infarction, COPD, chronic renal failure, decompensated cirrhosis, or other conditions affecting study participation
  • History of abnormal pap smear within 12 months
  • Insertion of levonorgestrel-containing IUD within 3 months prior to study entry
  • Breastfeeding or pregnant within 24 weeks prior to study entry
  • Use of probiotics or prebiotics (oral or vaginal) within 30 days prior to study
  • Routine use of oral antibiotics within past 30 days
  • Taken non-metronidazole antibiotics in last 30 days
  • Body mass index (BMI) greater than 40

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

Loading map...

Research Team

D

Doug Kwon, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here