Vaginal Microbiota Transplant
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.
| Condition(s) | Recurrent Bacterial Vaginosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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 | 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 dys |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Lead sponsor | Douglas Kwon |
| Locations | Boston, Massachusetts, United States |
| Start date | 2021-04-22 |
| NCT ID | NCT04046900 |
| Official listing | https://clinicaltrials.gov/study/NCT04046900 |