Could a 'Microbiome Transplant' stop recurring vaginal infections?
NCT ID NCT04046900
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study tests whether transplanting vaginal fluid from healthy donors can restore a healthy bacterial balance in women with recurrent bacterial vaginosis (BV). Participants receive either the transplant or a placebo after antibiotic treatment. The goal is to see if the transplant helps maintain protective Lactobacillus bacteria and prevent BV from coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vaginal microbiome transplant (donor vaginal fluid)
- What this could lead to
- If successful, this approach could offer a new way to prevent recurrent bacterial vaginosis by restoring healthy vaginal bacteria.
- What could go wrong
- This is an early-phase trial with a small number of participants. The transplant may not take hold, or side effects could occur. Results may not apply to all women.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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