Vaginal Microbiota Transplant

Conditions

• Recurrent Bacterial Vaginosis

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Vaginal microbiome transplant — BIOLOGICAL
  Vaginal fluid from healthy donors
• Oral Metronidazole — DRUG
  500mg oral metronidazole twice daily for 7 days
• Sterile saline — OTHER
  700 uL of sterile saline placed in the vagina as a placebo intervention.

Study Details

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.

Key Dates

Start date

Apr 22, 2021

Status verified

Jul 2025

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

62 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Vaginal microbiome transplant
  Women in this group will be randomized to receive two doses of vaginal fluid from a healthy donor
• Placebo Comparator: Saline placebo
  Women in this group will be randomized to receive two doses of sterile saline

Primary Outcome Measure

Presence of Lactobacillus crispatus-dominant microbiome [ Time Frame: 5 weeks after intervention ]

Central Contacts

• Doug Kwon, MD, PhD
  857-268-7009
  [email protected]

Locations (1)

Find similar trials in Boston, MA