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New treatment option for Recurrent Bacterial Vaginosis
Official title Vaginal Microbiota Transplant
ClinicalTrials.gov ID: NCT04046900
What this study is testing
What is Vaginal microbiome transplant?
Vaginal microbiome transplant is an investigational medicine, being studied as a potential treatment for recurrent bacterial vaginosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join 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...
- Condoms (male or female), with or without a spermicidal agent
You likely can't join if
- History of clinically significant vaginal, cervical, or uterine disease including but not limited to: cancer of the female reproductive tract, prior...
- 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...
- History of coronary artery disease, myocardial infarction, COPD, chronic renal failure, decompensated cirrhosis, or any other condition that in the...
- History of abnormal pap smear within 12 months
See the full eligibility 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...
- Condoms (male or female), with or without a spermicidal agent
- Intrauterine device (IUD)
- Hormonal contraceptive (including oral pills, vaginal ring, implant, injection)
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.