NCT04046900 Vaginal Microbiota Transplant
| NCT ID | NCT04046900 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Douglas Kwon |
| Condition | Recurrent Bacterial Vaginosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2021-04-22 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 62 participants in total. It began in 2021-04-22 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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) Exclusion Criteria: * 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
Contact & Investigator
Doug Kwon, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04046900 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Recurrent Bacterial Vaginosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04046900 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04046900 currently recruiting?
Yes, NCT04046900 is actively recruiting participants. Contact the research team at dkwon@mgh.harvard.edu for enrollment information.
Where is the NCT04046900 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04046900 clinical trial?
NCT04046900 is sponsored by Douglas Kwon. The principal investigator is Doug Kwon, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 62 participants.