Vaginal Microbiota Transplant to Promote Lactobacillus-dominant Cervicovaginal Communities
Douglas Kwon
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.
Description
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 donor…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
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)…
Interventions
- BiologicalVaginal microbiome transplant
Vaginal fluid from healthy donors
- DrugOral Metronidazole
500mg oral metronidazole twice daily for 7 days
- OtherSterile saline
700 uL of sterile saline placed in the vagina as a placebo intervention.
Location
- Massachusetts General HospitalBoston, Massachusetts