Vaginal Microbiota Transplant
ConditionRecurrent Bacterial Vaginosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorDouglas Kwon
About this trial
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.
Eligibility criteria
Qualifiers
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)
Condoms (male or female), with or without a spermicidal agent
Disqualifiers
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.
Allergy to metronidazole
Use of investigational therapies or investigational vaccines within 90 days prior to study entry
Use of any immunomodulatory agents within 30 days prior to study enrollment. Subject taking any of the following medications: systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g. local injection of interferon alpha for treatment of HPV is permitted) or systemic chemotherapy.
Trial design
Treatments tested in this trial
- Vaginal microbiome transplant
- Oral Metronidazole
- Sterile saline
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Douglas Kwon
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Source ClinicalTrials.gov