Transplanting vaginal microbiota to treat recurrent bacterial vaginosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the safety and effectiveness of vaginal microbiota transplant (VMT) compared to a saline placebo in women suffering from recurrent bacterial vaginosis (BV). It is a randomized, double-blind, placebo-controlled study that aims to establish a Lactobacillus-dominant vaginal community through VMT following antibiotic treatment. Participants will receive vaginal fluid from healthy donors, who are rigorously screened for infections, to ensure safety. The study includes multiple visits for treatment and follow-up assessments over several weeks.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Doug Kwon, MD, PhD — Massachusetts General Hospital
• Study coordinator: Doug Kwon, MD, PhD
• Email: dkwon@mgh.harvard.edu
• Phone: 857-268-7009

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can Lactobacillus crispatus CRP21 reduce recurrent bacterial vaginosis after antibiotics?

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• GenSci142 as a vaginal treatment for bacterial vaginosis

  This study tests whether GenSci142 given as vaginal doses is safe and may help BV patients aged 18–50 compared with clindamycin cream.

  Recruiting at 9 sites Phase 1 Changchun GeneScience Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality and 8 other locations · NCT07663838

• Vaginal gel to treat and prevent bacterial vaginosis and yeast infections

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• Using a device to treat bacterial vaginosis and fungal infections in women

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• Examining the genital microbiome of male partners of women with recurrent bacterial vaginosis

  This study is testing if the bacteria in the genital area of men can affect how often their female partners get bacterial vaginosis and whether cleaning with a certain solution can help reduce this risk.

  Recruiting Hadassah Medical Organization · Jerusalem · NCT05963711

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.