Vaginal Microbiota Transplant for Recurrent Bacterial Vaginosis

This study is looking at a new way to treat recurrent bacterial vaginosis (BV), a common vaginal infection. It's testing whether a vaginal microbiome transplant (VMT) can help restore healthy bacteria in the vagina. You might be eligible if you are a premenopausal woman between 18 and 50 years old, have had three or more BV episodes in the past year, and have an abnormal Nugent score (a way to measure vaginal bacteria). Participants will receive either vaginal fluid from healthy donors (VMT) or sterile saline (a placebo) after taking oral metronidazole, an antibiotic. The main goal is to see if VMT helps establish a healthy Lactobacillus-dominant vaginal community five weeks after the treatment. The study's current status is unclear.

Study design: This is a randomized, double-blind, placebo-controlled trial with a planned enrollment of 62 women. This means participants will be randomly assigned to receive either the active treatment or a placebo, and neither you nor the study staff will know which you are receiving.
What's involved: After a phone screen and a screening visit, you would have two treatment visits and six follow-up visits over 27 weeks. The baseline visit will be within 45 days of screening.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 27 weeks after the vaginal microbiota transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Vaginal Microbiota Transplant

Recruiting

PHASE1Ages 18–50InterventionalPrevention

Douglas Kwon

~62 participants

Updated 2026-09-11 on ClinicalTrials.gov

What's tested:Vaginal microbiome transplantOral MetronidazoleSterile saline

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Presence of Lactobacillus crispatus-dominant microbiome

Measured over 5 weeks after intervention

Conditions

Recurrent Bacterial Vaginosis

NCT04046900

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Massachusetts General Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Doug Kwon, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Doug Kwon, MD, PhD

[email protected]

857-268-7009

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

Presence of Lactobacillus crispatus-dominant microbiome5 weeks after intervention
Lactobacillus crispatus dominant = relative abundance of Lactobacillus crispatus in the vaginal microbial community \> 50%

Trialytics