Recruiting
Phase 1
Phase 2

Vaginal Microbiome Transplant

Sponsor:

Douglas Kwon

Code:

NCT04046900

Conditions

Recurrent Bacterial Vaginosis

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Vaginal microbiome transplant

Oral Metronidazole

Sterile saline

Study Details

Brief 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

Study ID

NCT04046900

Start date

Apr 22, 2021

Status verified date

Jul, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Premenopausal women, 18- 50 years old
  • Abnormal Nugent score: > 3
  • History of recurrent bacterial vaginosis (BV) (3 or more documented episodes in past 12 months)
  • If participating in sexual activity that could lead to pregnancy, study participants must agree to use an effective contraceptive while actively participating in the protocol. At least one of the following methods MUST be used:

  • Condoms (male or female), with or without a spermicidal agent
  • Intrauterine device (IUD)
  • Hormonal contraceptive (including oral pills, vaginal ring, implant, injection)

Exclusion Criteria:

  • History of clinically significant vaginal, cervical, or uterine disease including but not limited to: cancer of the female reproductive tract, prior hysterectomy, high grade cervical dysplasia (CIN III), or diagnosed with cervicovaginal infection (with the exception of bacterial vaginosis) within the 30 days prior to the procedure.

  • Allergy to metronidazole
  • Use of investigational therapies or investigational vaccines within 90 days prior to study entry
  • Use of any immunomodulatory agents within 30 days prior to study enrollment. Subject taking any of the following medications: systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g. local injection of interferon alpha for treatment of HPV is permitted) or systemic chemotherapy.
  • History of coronary artery disease, myocardial infarction, COPD, chronic renal failure, decompensated cirrhosis, or any other condition that in the opinion of the investigator will compromise ability to participate in the study.
  • History of abnormal pap smear within 12 months
  • Insertion of levonorgestrel-containing IUD within 3 months prior to study entry
  • Either breastfeeding or pregnant within 24 weeks prior to study entry
  • Use of probiotics and prebiotics (supplements and products, oral or vaginal) within 30 days of the study. (NOTE: Oral yogurt with live cultures is allowed.)
  • Routine use of oral antibiotics i.e. daily use for acne, Hidradenitis suppurativa, or regular use for post-coital urinary tract infection prophylaxis within the past 30 days.
  • Taken non-metronidazole antibiotics in last 30 days
  • BMI > 40

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Vaginal microbiome transplant

Women in this group will be randomized to receive two doses of vaginal fluid from a healthy donor

placebo comparator: Saline placebo

Women in this group will be randomized to receive two doses of sterile saline

Interventions

Vaginal microbiome transplant

Vaginal fluid from healthy donors

Oral Metronidazole

500mg oral metronidazole twice daily for 7 days

Sterile saline

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

Primary outcome measure

  • Presence of Lactobacillus crispatus-dominant microbiome [ Time Frame: 5 weeks after intervention ]

Central Contacts and Locations

Central contacts

Doug Kwon, MD, PhD

857-268-7009dkwon@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Caroline Mitchell, MD, MPH

617-724-2182caroline.mitchell@mgh.harvard.edu

Principal Investigator:

Caroline Mitchell, MD, MPH

More Information

Sponsor

Douglas Kwon

Last update posted

Jul 6, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Douglas Kwon on 2026-07-06.