Vaginal Microbiota Transplant

NCT04046900 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2019P001543
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Presence of Lactobacillus crispatus-dominant microbiome

  Lactobacillus crispatus dominant = relative abundance of Lactobacillus crispatus in the vaginal microbial community \> 50%

  5 weeks after intervention

Secondary Outcomes (3)

• Presence of Lactobacillus-dominant microbiome

  1, 3, 5, 7 weeks, 4 and 6 months after intervention

• Number of women reporting adverse events

  1, 3, 5, 7 weeks, 4 and 6 months after intervention

• Presence of Lactobacillus crispatus-dominant microbiome

  1, 3, 7 weeks, 4 and 6 months after intervention

Study Arms (2)

Vaginal microbiome transplant

ACTIVE COMPARATOR

Women in this group will be randomized to receive two doses of vaginal fluid from a healthy donor

Biological: Vaginal microbiome transplant; Drug: Oral Metronidazole

Saline placebo

PLACEBO COMPARATOR

Women in this group will be randomized to receive two doses of sterile saline

Drug: Oral Metronidazole; Other: Sterile saline

Interventions

Vaginal microbiome transplant BIOLOGICAL

Vaginal fluid from healthy donors

Vaginal microbiome transplant

Oral Metronidazole DRUG

500mg oral metronidazole twice daily for 7 days

Saline placebo; Vaginal microbiome transplant

Sterile saline OTHER

700 uL of sterile saline placed in the vagina as a placebo intervention.

Saline placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• History of coronary artery disease, myocardial infarction, COPD, chronic renal failure, decompensated cirrhosis, or any other condition that in the opinion of the investigator will compromise ability to participate in the study.
• History of abnormal pap smear within 12 months
• Insertion of levonorgestrel-containing IUD within 3 months prior to study entry
• Either breastfeeding or pregnant within 24 weeks prior to study entry
• Use of probiotics and prebiotics (supplements and products, oral or vaginal) within 30 days of the study. (NOTE: Oral yogurt with live cultures is allowed.)
• Routine use of oral antibiotics i.e. daily use for acne, Hidradenitis suppurativa, or regular use for post-coital urinary tract infection prophylaxis within the past 30 days.
• Taken non-metronidazole antibiotics in last 30 days
• BMI \> 40

Sponsors & Collaborators

• Douglas Kwon: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Doug Kwon, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doug Kwon, MD, PhD

CONTACT

857-268-7009; dkwon@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Participants will be randomized 2:1 to VMT vs. placebo. An initial pilot of 8 people will be enrolled and safety assessed (with unblinding and comparison of the arms) before proceeding with the larger study of 54 people, which will be analyzed separately.

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 6, 2019
• Study Start: April 22, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)