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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Presence of Lactobacillus crispatus-dominant microbiome