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
Among 82 studies in Vaginosis, Bacterial with a site in United States — 8 open to participants now, 8 under way, none of them phase 3. Vaginosis, Bacterial · United States.
Among the 82 studies in Vaginosis, Bacterial with a site in United States, this one is the 38th largest by planned enrollment of the 69 interventional ones that give a count, is one of 6 that started in 2021, is one of 3 in phase 1/2, and was the 59th registered.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
Browse Vaginosis, Bacterial studies →8 of the 82 studies in Vaginosis, Bacterial with a site in United States are open now. Recruiting first, the newest first:
Nanopath, Inc · Sites in United States
Ages 18+ · Women only
Tulane University · Sites in United States
Ages 18+ · Healthy volunteers
Cern Corporation · Sites in United States
Ages 18+ · Women only
Queen's Medical Center · Sites in United States
Ages 18–54 · Women only · Healthy volunteers
Texas Tech University Health Sciences Center · Sites in United States
Ages 21–75 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 23 Vaginosis, Bacterial studies recruiting now, 7 (30%) set no upper age limit and 16 (70%) stop at 75 or younger; 2 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 50 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 19 · Phase 3 14 · Phase 4 10
First in 1999; this study’s year is marked. 6 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 62 is below the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.
Median enrollment 81 across the 69 interventional studies, 519 across the 13 observational. Of the 66 that completed or were terminated, 30 (45%) have results posted.
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30 of 82 have an industry lead sponsor. The 10 most frequent:
Douglas Kwon is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Douglas Kwon has 2 studies filed under Vaginosis, Bacterial — fewer than ten, so there is no comparison to draw.
4 of the studies in Vaginosis, Bacterial with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07607470Nanopath, IncLarge Algorithm Setting and Validation Study | 2026-12 |
| NCT04046900Douglas KwonVaginal Microbiota Transplant | 2027-01-30 |
| NCT06472765Vaginal Biome ScienceVaginal Ecosystem and Network in the United States Study | 2027-05-15 |
| NCT01829204Texas Tech University Health Sciences CenterProspective Data Bank Creation to Study Vaginal Conditions | 2027-07 |
Add all 4 to your calendar (.ics) → With an account.
Among the 82 studies in Vaginosis, Bacterial with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If participating in sexual activity that could lead to pregnancy, study participants must agree to use an effective while actively participating in the protocol. At least one of the following methods MUST be used:
Exclusion Criteria:
History of 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for Jan 2027, 69 months after the start.
How these figures are worked out, and which studies are left out of them.
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Douglas Kwon