A Phase 1/2 interventional study of Vaginal microbiome transplant and Oral Metronidazole in Recurrent Bacterial Vaginosis, sponsored by Douglas Kwon. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Douglas Kwon · Phase 1/2, Interventional, and Prevention
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.
The investigators propose a randomized, double-blind, placebo-controlled trial to evaluate the safety of vaginal microbiota transplant (VMT) in women with recurrent bacterial vaginosis (BV), and to assess the ability of antibiotic treatment plus vaginal microbiota transplant to establish a Lactobacillus-dominant vaginal community as compared to antibiotic treatment alone. The underlying hypothesis is that the VMT will lead to less inflammation and higher prevalence of vaginal Lactobacillus compared to antibiotics alone. The transplant material will be vaginal fluid collected from healthy donors using a disposable menstrual cup. Donors undergo extensive testing for possible infections to ensure the safety of the donated material.
Study Visits and Procedures: In addition to the pre-screening eligibility phone call and screening visit, there will be two treatment study visits and six post-VMT follow up visits at weeks 3, 5, 7, 11, 15, and 27. The baseline visit will occur within 45 days of the screening visit.
Phone Screen: A brief phone discussion to explain approach and alternatives (see details below in "Technical Methods"). A set of short screening questions will be asked to identify women with clear exclusion criteria for participation.
Visit 1, Screening Visit: At the screening visit, after written informed consent is obtained, the information from the pre-screening questionnaire will be reviewed with the subject and updated as necessary. Blood and vaginal specimens will be collected. The VMT process will be explained in detail and subjects will have the opportunity to inspect an example applicator if interested. Subjects will be counseled not to have vaginal intercourse or insert anything into their vagina from the 72 hours prior to the first transplant dose until 72 hours after the second transplant dose.
Visit 2: Baseline, Week 1 (occurs immediately prior to menses)
Visit 3: First Transplant Administration, Week 2
Visit 4: Second Transplant Administration, Week 2
Visits 5-10: Post-transplant follow ups, Weeks 3, 5, 7, 11, 15, 27
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:
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.
Women in this group will be randomized to receive two doses of vaginal fluid from a healthy donor
Biological: Vaginal microbiome transplant · Drug: Oral Metronidazole
Women in this group will be randomized to receive two doses of sterile saline
Drug: Oral Metronidazole · Other: Sterile saline
Vaginal fluid from healthy donors
500mg oral metronidazole twice daily for 7 days
700 uL of sterile saline placed in the vagina as a placebo intervention.
Presence of Lactobacillus crispatus-dominant microbiome
Lactobacillus crispatus dominant = relative abundance of Lactobacillus crispatus in the vaginal microbial community \> 50%
Time frame: 5 weeks after intervention
Presence of Lactobacillus-dominant microbiome
Characterization of the vaginal microbial community using 16S rRNA sequencing
Time frame: 1, 3, 5, 7 weeks, 4 and 6 months after intervention
Number of women reporting adverse events
Report of adverse events
Time frame: 1, 3, 5, 7 weeks, 4 and 6 months after intervention
Presence of Lactobacillus crispatus-dominant microbiome
Characterization of the vaginal microbial community using 16S rRNA sequencing
Time frame: 1, 3, 7 weeks, 4 and 6 months after intervention
Plan to share: No
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Douglas Kwon