Recurrent Bacterial Vaginosis Clinical Trial
Official title:
Vaginal Microbiota Transplant to Promote Lactobacillus-dominant Cervicovaginal Communities
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. - Review eligibility and understand/see applicator - Obtain informed consent - Height, weight measurements - Subjects will be given information about how to perform vaginal swab collections (see vaginal swab collection document) - Physical exam - Pelvic exam - Screening labs: Complete blood cell count w/ differential, comprehensive metabolic panel, Pap/HPV (human papillomavirus) testing, gonorrhea, chlamydia, trichomonas testing. HIV, Hepatitis B&C, Herpes. - Urine pregnancy test - Behavior and sexual assessment Visit 2: Baseline, Week 1 (occurs immediately prior to menses) - Self-Administered Vaginal Swab and soft cup collection - Blood draw - Pelvic Exam: cervical swabs, cytobrush - Symptom and Sexual Behavior Assessment - Assignment into study groups using block randomization - Subjects will be given 7-day course of: Metronidazole 500mg PO every 12 hours Visit 3: First Transplant Administration, Week 2 - Self-collected Vaginal Swab and soft cup collection - Pelvic Exam: VMT/placebo Administration - Symptom and Sexual Behavior Assessment Visit 4: Second Transplant Administration, Week 2 - Self-Administered Vaginal Swab - Pelvic Exam: VMT/Placebo Administration - Symptom and Sexual Behavior Assessment Visits 5-10: Post-transplant follow ups, Weeks 3, 5, 7, 11, 15, 27 - Blood draw (visit 7 only) - Self-Administered Vaginal Swab - Self-Administered soft cup collection (visit 5, 7 & 9) - Symptom and Sexual Behavior Assessment - Pelvic Exam: cervical swabs, cytobrush (visits 7 & 9) ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05033743 -
Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
|
Phase 2/Phase 3 | |
| Completed |
NCT02209519 -
Randomized Controlled Trial of Treatment of Male Partners of Women With BV
|
Phase 3 | |
| Withdrawn |
NCT00324142 -
A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis
|
Phase 2 |