Transplanting vaginal microbiota to treat recurrent bacterial vaginosis

Vaginal Microbiota Transplant to Promote Lactobacillus-dominant Cervicovaginal Communities

This study is testing if a vaginal microbiota transplant can help women with recurring bacterial vaginosis feel better compared to a saline solution.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Massachusetts General Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04046900 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are premenopausal women aged 18-50 with a history of recurrent bacterial vaginosis and an abnormal Nugent score.

Not a fit: Patients with significant vaginal, cervical, or uterine diseases or those allergic to metronidazole may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence of bacterial vaginosis and improve women's vaginal health.

How similar studies have performed: While the concept of microbiota transplant is gaining traction, this specific approach for treating recurrent bacterial vaginosis is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Boston, Massachusetts

• 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

Conditions: Recurrent Bacterial Vaginosis