Recurrent Bacterial VaginosisPhase 1/2MOTIFNCT04046900
Vaginal Microbiota Transplant
A Phase 1/2 study testing Vaginal microbiome transplant, Oral Metronidazole and Sterile saline in people with Recurrent Bacterial Vaginosis, run by Douglas Kwon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Recurrent Bacterial Vaginosis
- What is being tested?
- Vaginal microbiome transplant, Oral Metronidazole and Sterile saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2021to 30 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Caroline Mitchell, MD, MPH, 617-724-2182, caroline.mitchell@mgh.harvard.edu
Caroline Mitchell, MD, MPH
About this study
Official title: Vaginal Microbiota Transplant to Promote Lactobacillus-dominant Cervicovaginal Communities
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.
Read the detailed description
The investigators propose a randomized, double-blind, placebo-controlled trial to evaluate the safety of vaginal microbiota transplant (VMT) in women with recurrent bacterial vaginosis (BV), and to assess the ability of antibiotic treatment plus vaginal microbiota transplant to establish a Lactobacillus-dominant vaginal community as compared to antibiotic treatment alone. The underlying hypothesis is that the VMT will lead to less inflammation and higher prevalence of vaginal Lactobacillus compared to antibiotics alone. The transplant material will be vaginal fluid collected from healthy donors using a disposable menstrual cup. Donors undergo extensive testing for possible infections to ensure the safety of the donated material.
Study Visits and Procedures: In addition to the pre-screening eligibility phone call and screening visit, there will be two treatment study visits and six post-VMT follow up visits at weeks 3, 5, 7, 11, 15, and 27. The baseline visit will occur within 45 days of the screening visit.
Phone Screen: A brief phone discussion to explain approach and alternatives (see details below in "Technical Methods"). A set of short screening questions will be asked to identify women with clear exclusion criteria for participation.
Visit 1, Screening Visit: At the screening visit, after written informed consent is obtained, the information from the pre-screening questionnaire will be reviewed with the subject and updated as necessary. Blood and vaginal specimens will be collected. The VMT process will be explained in detail and subjects will have the opportunity to inspect an example applicator if interested. Subjects will be counseled not to have vaginal intercourse or insert anything into their vagina from the 72 hours prior to the first transplant dose until 72 hours after the second transplant dose.
- Review eligibility and understand/see applicator
- Obtain informed consent
- Height, weight measurements
- Subjects will be given information about how to perform vaginal swab collections (see vaginal swab collection document)
- Physical exam
- Pelvic exam
- Screening labs: Complete blood cell count w/ differential, comprehensive metabolic panel, Pap/HPV (human papillomavirus) testing, gonorrhea, chlamydia, trichomonas testing. HIV, Hepatitis B\&C, Herpes.
- Urine pregnancy test
- Behavior and sexual assessment
Visit 2: Baseline, Week 1 (occurs immediately prior to menses)
- Self-Administered Vaginal Swab and soft cup collection
- Blood draw
- Pelvic Exam: cervical swabs, cytobrush
- Symptom and Sexual Behavior Assessment
- Assignment into study groups using block randomization
- Subjects will be given 7-day course of: Metronidazole 500mg PO every 12 hours
Visit 3: First Transplant Administration, Week 2
- Self-collected Vaginal Swab and soft cup collection
- Pelvic Exam: VMT/placebo Administration
- Symptom and Sexual Behavior Assessment
Visit 4: Second Transplant Administration, Week 2
- Self-Administered Vaginal Swab
- Pelvic Exam: VMT/Placebo Administration
- Symptom and Sexual Behavior Assessment
Visits 5-10: Post-transplant follow ups, Weeks 3, 5, 7, 11, 15, 27
- Blood draw (visit 7 only)
- Self-Administered Vaginal Swab
- Self-Administered soft cup collection (visit 5, 7 \& 9)
- Symptom and Sexual Behavior Assessment
- Pelvic Exam: cervical swabs, cytobrush (visits 7 \& 9)
- Conditions
- Recurrent Bacterial Vaginosis
- Being tested
- Vaginal microbiome transplant, Oral Metronidazole, Sterile saline
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal microbiome transplantBiological
Vaginal fluid from healthy donors
Oral MetronidazoleDrug
500mg oral metronidazole twice daily for 7 days
Sterile salineOther
700 uL of sterile saline placed in the vagina as a placebo intervention.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal microbiome transplant | Active comparator | Women in this group will be randomized to receive two doses of vaginal fluid from a healthy donor Receives: 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 Receives: Drug: Oral Metronidazole; Other: Sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Lactobacillus crispatus-dominant microbiome
Lactobacillus crispatus dominant = relative abundance of Lactobacillus crispatus in the vaginal microbial community > 50%
Measured: 5 weeks after intervention
Secondary outcomes (3)
Presence of Lactobacillus-dominant microbiome
Characterization of the vaginal microbial community using 16S rRNA sequencing
Measured: 1, 3, 5, 7 weeks, 4 and 6 months after intervention
Number of women reporting adverse events
Report of adverse events
Measured: 1, 3, 5, 7 weeks, 4 and 6 months after intervention
Presence of Lactobacillus crispatus-dominant microbiome
Characterization of the vaginal microbial community using 16S rRNA sequencing
Measured: 1, 3, 7 weeks, 4 and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start22 Apr 2021
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Kwon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Douglas Kwon, Massachusetts General Hospital
- Investigators
- Doug Kwon, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046900
- Sponsor's protocol ID
- 2019P001543
- Acronym
- MOTIF
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2019
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Microbiota Transplant to Promote Lactobacillus-dominant Cervicovaginal Communities
- ClinicalTrials.gov ID
- NCT04046900
- Acronym / sponsor ID
- MOTIF / 2019P001543
- Conditions
- Recurrent Bacterial Vaginosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Douglas KwonUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators propose a randomized, double-blind, placebo-controlled trial to evaluate the safety of vaginal microbiota transplant (VMT) in women with recurrent bacterial vaginosis (BV), and to assess the ability of antibiotic treatment plus vaginal microbiota transplant to establish a Lactobacillus-dominant vaginal community as compared to antibiotic treatment alone. The underlying hypothesis is that the VMT will lead to less inflammation and higher prevalence of vaginal Lactobacillus compared to antibiotics alone. The transplant material will be vaginal fluid collected from healthy donors using a disposable menstrual cup. Donors undergo extensive testing for possible infections to ensure the safety of the donated material.
Study Visits and Procedures: In addition to the pre-screening eligibility phone call and screening visit, there will be two treatment study visits and six post-VMT follow up visits at weeks 3, 5, 7, 11, 15, and 27. The baseline visit will occur within 45 days of the screening visit.
Phone Screen: A brief phone discussion to explain approach and alternatives (see details below in "Technical Methods"). A set of short screening questions will be asked to identify women with clear exclusion criteria for participation.
Visit 1, Screening Visit: At the screening visit, after written informed consent is obtained, the information from the pre-screening questionnaire will be reviewed with the subject and updated as necessary. Blood and vaginal specimens will be collected. The VMT process will be explained in detail and subjects will have the opportunity to inspect an example applicator if interested. Subjects will be counseled not to have vaginal intercourse or insert anything into their vagina from the 72 hours prior to the first transplant dose until 72 hours after the second transplant dose.
- Review eligibility and understand/see applicator
- Obtain informed consent
- Height, weight measurements
- Subjects will be given information about how to perform vaginal swab collections (see vaginal swab collection document)
- Physical exam
- Pelvic exam
- Screening labs: Complete blood cell count w/ differential, comprehensive metabolic panel, Pap/HPV (human papillomavirus) testing, gonorrhea, chlamydia, trichomonas testing. HIV, Hepatitis B\&C, Herpes.
- Urine pregnancy test
- Behavior and sexual assessment
Visit 2: Baseline, Week 1 (occurs immediately prior to menses)
- Self-Administered Vaginal Swab and soft cup collection
- Blood draw
- Pelvic Exam: cervical swabs, cytobrush
- Symptom and Sexual Behavior Assessment
- Assignment into study groups using block randomization
- Subjects will be given 7-day course of: Metronidazole 500mg PO every 12 hours
Visit 3: First Transplant Administration, Week 2
- Self-collected Vaginal Swab and soft cup collection
- Pelvic Exam: VMT/placebo Administration
- Symptom and Sexual Behavior Assessment
Visit 4: Second Transplant Administration, Week 2
- Self-Administered Vaginal Swab
- Pelvic Exam: VMT/Placebo Administration
- Symptom and Sexual Behavior Assessment
Visits 5-10: Post-transplant follow ups, Weeks 3, 5, 7, 11, 15, 27
- Blood draw (visit 7 only)
- Self-Administered Vaginal Swab
- Self-Administered soft cup collection (visit 5, 7 \& 9)
- Symptom and Sexual Behavior Assessment
- Pelvic Exam: cervical swabs, cytobrush (visits 7 \& 9)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vaginal microbiome transplant | Active comparator | Biological: Vaginal microbiome transplant, Drug: Oral MetronidazoleWomen in this group will be randomized to receive two doses of vaginal fluid from a healthy donor |
| Saline placebo | Placebo comparator | Drug: Oral Metronidazole, Other: Sterile salineWomen in this group will be randomized to receive two doses of sterile saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal microbiome transplantVaginal fluid from healthy donors | Biological | Vaginal microbiome transplant |
| Oral Metronidazole500mg oral metronidazole twice daily for 7 days | Drug | Saline placebo, Vaginal microbiome transplant |
| Sterile saline700 uL of sterile saline placed in the vagina as a placebo intervention. | Other | Saline placebo |
Primary outcome
Presence of Lactobacillus crispatus-dominant microbiome
Time frame: 5 weeks after intervention
Lactobacillus crispatus dominant = relative abundance of Lactobacillus crispatus in the vaginal microbial community > 50%
3 secondary outcomes
Presence of Lactobacillus-dominant microbiome
Time frame: 1, 3, 5, 7 weeks, 4 and 6 months after intervention
Number of women reporting adverse events
Time frame: 1, 3, 5, 7 weeks, 4 and 6 months after intervention
Presence of Lactobacillus crispatus-dominant microbiome
Time frame: 1, 3, 7 weeks, 4 and 6 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doug Kwon, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vaginal microbiome transplant, Oral Metronidazole and Sterile saline in people with Recurrent Bacterial Vaginosis, run by Douglas Kwon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doug Kwon, MD, PhD (857-268-7009, dkwon@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Lactobacillus crispatus-dominant microbiome (time frame: 5 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.