Bacterial VaginosisPhase 1NCT03769688
Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV)
A Phase 1 study testing Cervicovaginal secretions, Metronidazole gel and Screening tests in people with Bacterial Vaginosis, run by Johns Hopkins University.
Trial summary
The composition of a woman's vaginal microbiota has a significant impact on her reproductive tract health and general quality of life. Approximately one-third of all women currently have bacterial vaginosis (BV), a polymicrobial condition in which the vaginal microbiota is not dominated by Lactobacillus species… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Cervicovaginal secretions, Metronidazole gel and Screening tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion criteria that apply to potential Donor participants:
- Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures.
- Generally healthy, pre-menopausal women age 18-45 years old.
- Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of long-acting progestin or continuous use of oral contraceptives.
- Free of vaginal symptoms, such as odor, discharge, or itching.
- Willing to be asked questions about personal medical, sexual, and behavioral history.
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- Willing to self-collect cervicovaginal secretions and vaginal swab samples.
- Agree to abstain from using insertive vaginal feminine products (i.e. Tampons, menstrual cups, sex toys), other vaginal products (cleansing products, spermicides, lubricants, hygiene powders and sprays), vaginal and anal intercourse, taking baths, going swimming, sitting in hot tub, or wearing thong underwear during the entire sample donation period (from screening to the final donation). Sanitary napkins are acceptable.
- Inclusion criteria that apply to potential Recipient participants:
- Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures.
- Generally healthy, pre-menopausal women age 18-45 years old.
- Experiences recurrent bacterial vaginosis (BV) (at least 3 diagnoses in their lifetime), and has received treatment for BV on at least 1 prior occasion in the past 5 years.
- Currently needing treatment for vaginal symptoms clinically diagnosed as BV (>= 3 Amsel criteria and confirmed in the laboratory by Nugent score >= 4) and suitable for 0.75% metronidazole vaginal antibiotic treatment.
- Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of long-acting progestin or continuous use of oral contraceptives.
- Women who are not sterilized or who are not using an Intra-uterine Device (IUD) or form of hormonal contraception must agree to barrier contraception (i.e. Condoms, diaphragm) for heterosexual intercourse during the study. Counseling will be provided for use of barrier contraception without the use of adjunctive spermicide or lubricant.
- Willing to be asked questions about personal medical, sexual, and behavioral history.
- Willing to self-collect cervicovaginal secretions and vaginal swab samples.
- Willing to undergo VMT procedure.
- Agree to abstain from vaginal intercourse, unless using a condom, for at least the 28 days after the VMT procedure. Condoms will be provided.
- Agree to avoid taking baths, swimming, sitting in a hot tub, or wearing thong underwear for at least the 28 days after the VMT procedure.
- Agree to abstain from using insertive vaginal feminine products (i.e. Tampons, menstrual cups, sex toys), vaginal cleansing products, spermicides, lubricants, or other vaginal products not approved by the study investigators after the VMT procedure through visit 8 (~6 months). Sanitary napkins are acceptable.
Who cannot join
- Exclusion criteria that apply to potential Donor participants:
- Any history of bacterial vaginosis, recurrent yeast infection, trichomoniasis, syphilis, human papilloma virus (HPV) including genital warts, high grade pap smear, herpes, pelvic inflammatory disease, recurrent urinary tract infection, mycoplasma.
- Testing positive for HIV, Hepatitis A/B/C, syphilis, Human T-lymphotrophic Virus (HTLV)-I/II, WNV, Epstein-Barr Virus (EBV), rubella, toxoplasma gondii, Herpes Simplex Virus (HSV)-1/2, yeast or bacteria that are considered pathogenic/abnormal and/or show antibiotic resistance, chlamydia, gonorrhea, mycoplasma genitalium, trichomonas vaginalis, HPV.
- Cervicovaginal secretions (CVS) not dominated by one of the common vaginal lactobacillus species, as determined by qPCR.
- Currently pregnant or breastfeeding.
- History of gonorrhea or chlamydia within 12 months prior to screening.
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- Travel or sexual partner travel to regions or countries where Ebola or Zika outbreaks occurred in the past 12 months.
- Any other medical, travel, or behavioral history that deems donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) ineligible.
- HIV/AIDS or other immunodeficiency, or testing out of the range of normal clinical parameters for general measures of immunocompetence.
- Hysterectomy.
- Use of vaginal ring (e.g., NuvaRing) within 3 days of screening or during the course of the study.
- Investigational drug use within 30 days or 10 half-lives of the drug, whichever is longer, of enrollment visit, or planned participation in an investigational drug study while participating in this study.
- IUD insertion or removal, cervical cryotherapy, or cervical laser treatment within 2 months prior to screening.
- Any condition requiring regular periodic use of systemic antibiotics during the study.
- New use of long-acting hormonal treatments. Participant may be enrolled if stable (>3 months) or existing therapy as determined by the investigator.
- Any social, medical, or psychiatric condition, including history of drug or alcohol abuse that in the opinion of the investigator would make it unlikely for the participant to comply with the study or would complicate interpretation of data from her participation.
- Menopause defined as more than 12 consecutive months of amenorrhea without another known cause.
- Irregular menstrual cycles that preclude scheduling appointments to avoid menstruation.
- Donors will be screened for cytomegalovirus (CMV), Rubella, and Varicella Zoster Virus (VZV) IgG, which will not be a criterion for exclusion, but samples from CMV positive and/or Rubella positive and/or VZV positive Donors will only be matched with CMV positive and/or Rubella and/or VZV positive Recipients.
- Abnormal finding on exam, which, in the opinion of the investigator, precludes participation.
- Sexual history or current sexual behavior, or having sexual partners that engage in such behaviors, which introduces increased risk of sexually transmitted infections or exposure to pathogenic organisms.
- Medication use, recent vaccinations, sources of income, or other behaviors, which in the opinion of the investigator, precludes participation.
- Exclusion Criteria that apply to potential Recipient participants
- Current pregnancy, within 2 months of pregnancy, planning to become pregnant within the next 6 months, and/or currently breastfeeding.
- HIV/AIDS or other immunodeficiency.
- Testing positive for HIV, HTLV-I/II, yeast infection, chlamydia, gonorrhea, mycoplasma genitalium, trichomonas, antibiotic-resistant bacteria in culture, or human Chorionic Gonadotrophin (hCG) (urine).
- Hysterectomy.
- High grade pap smear within the past year.
- Use of vaginal ring (e.g., NuvaRing) during the course of the study.
- Investigational drug use within 30 days or 10 half-lives of the drug, whichever is longer, of enrollment visit, or planned participation in an investigational drug study while participating in this study.
- IUD insertion or removal, cervical cryotherapy, or cervical laser treatment within 2 months prior to screening.
- Any condition requiring regular periodic use of systemic antibiotics during the study.
- New use of long-acting hormonal treatments. Participant may be enrolled if stable (>3 months) or existing therapy as determined by the investigator.
- Any social, medical, or psychiatric condition, including history of drug or alcohol abuse that in the opinion of the investigator would make it unlikely for the participant to comply with the study or would complicate interpretation of data from her participation.
- Menopause defined as more than 12 consecutive months of amenorrhea without another known cause.
- Recipients will be screened for cytomegalovirus (CMV), Rubella, and Varicella Zoster Virus (VZV) IgG, which will not be a criterion for exclusion, but samples from CMV positive and/or Rubella positive and/or VZV positive Donors will only be matched with CMV positive and/or Rubella and/or VZV positive Recipients.
- Abnormal finding on exam, which, in the opinion of the investigator, precludes participation.
About this study
Official title: VMT-01: Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV)
The composition of a woman's vaginal microbiota has a significant impact on her reproductive tract health and general quality of life. Approximately one-third of all women currently have bacterial vaginosis (BV), a polymicrobial condition in which the vaginal microbiota is not dominated by Lactobacillus species, leading to increased risk of various reproductive tract maladies and negative impact on well-being. It has been suggested by epidemiological studies that vaginal microbiota are readily transferable from one woman to another. Here, investigators aim to explore the hypothesis that vaginal microbiota can be engrafted from one woman to another in a controlled clinical setting by using cervicovaginal secretions (CVS), a process referred to as vaginal microbiota transplant (VMT).
- Conditions
- Bacterial Vaginosis
- Being tested
- Cervicovaginal secretions, Metronidazole gel, Screening tests, Activities restriction, Sterile Saline placebo
- Keywords
- bacterial vaginosis, cervicovaginal secretions, vaginal microbiota
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervicovaginal secretionsDrug
Same as arm descriptions
Metronidazole gelDrug
5 day course of vaginal MetroGel will be used prior to VMT intervention.
Screening testsDiagnostic test
Diagnostic testing for a broad range of infectious pathogens in blood, vaginal swab, and urine samples, for general immunocompetence, and for potential pregnancy.
Activities restrictionBehavioural
Required abstinence from sexual intercourse, usage of insertive vaginal feminine products (i.e. Tampons, menstrual cups, sex toys), other vaginal products (cleansing products, spermicides, lubricants, hygiene powders and sprays), and avoidance of behaviors including taking baths, going swimming, sitting in hot tub, or wearing thong underwear. Sanitary napkins are acceptable.
Sterile Saline placeboOther
This will be administered as a placebo in place of cervicovaginal secretions
| Study group | Role | What they receive |
|---|---|---|
| Cervicovaginal secretions | Experimental | Participants will receive standard of care antibiotics (vaginal Metronidazole gel). After standard antibiotic treatment, participants will receive a single intravaginal dose of cervicovaginal secretions (10 mg in 1 ml total volume, 0.9 ml normal saline). Receives: Drug: Cervicovaginal secretions; Drug: Metronidazole gel; Diagnostic Test: Screening tests; Behavioral: Activities restriction |
| Saline placebo | Placebo comparator | Participants will receive standard of care antibiotics (vaginal Metronidazole gel). After standard antibiotic treatment, participants will receive a single intravaginal dose of sterile saline placebo (1 ml total volume). Receives: Drug: Metronidazole gel; Diagnostic Test: Screening tests; Behavioral: Activities restriction; Other: Sterile Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteria engraftment as assessed by ribosomal (rDNA) gene sequencing
Detection of Donor vaginal Lactobacillus in Recipient by 16S rDNA gene sequencing (~1% or greater relative abundance by read count)
Measured: 28 days
Secondary outcomes (4)
Bacteria engraftment as assessed by rDNA gene sequencing
Detection of Donor vaginal Lactobacillus in Recipient by 16S rDNA gene sequencing (~1% or greater relative abundance by read count)
Measured: 10 days
Bacterial communities as assessed by rDNA gene sequencing
Identify bacterial communities colonizing the vagina at screening in women with bacterial vaginosis and after antibiotic and CVS treatment by 16S rDNA sequencing
Measured: At screening , and then follow-up (~7 months)
Bacterial vaginosis recurrence as assessed by Amsel's criteria
Determination of recurrence of BV in participants by Amsel's criteria. Amsel's criteria includes the presence of a homogeneous vaginal discharge, pH of the vagina being > 4.5, the presence of clue cells in gram stained vaginal discharge smears and a positive whiff test. According to Amsel, if 3 of the 4 criteria are positive, the patient has bacterial vaginosis
Measured: Up to 6 months after VMT procedure
Bacterial vaginosis recurrence as assessed by Nugent score
Determination of recurrence of BV in participants by Nugent score. The Nugent score is calculated by assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2). A total score of 7 to 10 is consistent with bacterial vaginosis without culture.
Measured: Up to 6 months after VMT procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study startMar 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Replaced with different study at another site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Ensign, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769688
- Sponsor's protocol ID
- NA_00090758
- Status last verified
- Oct 2021
- First submitted
- 6 Dec 2018
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VMT-01: Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV)
- ClinicalTrials.gov ID
- NCT03769688
- Acronym / sponsor ID
- NA_00090758
- Conditions
- Bacterial Vaginosis
- Keywords
- bacterial vaginosis, cervicovaginal secretions, vaginal microbiota
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replaced with different study at another site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Dec 2018 (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.
The composition of a woman's vaginal microbiota has a significant impact on her reproductive tract health and general quality of life. Approximately one-third of all women currently have bacterial vaginosis (BV), a polymicrobial condition in which the vaginal microbiota is not dominated by Lactobacillus species, leading to increased risk of various reproductive tract maladies and negative impact on well-being. It has been suggested by epidemiological studies that vaginal microbiota are readily transferable from one woman to another. Here, investigators aim to explore the hypothesis that vaginal microbiota can be engrafted from one woman to another in a controlled clinical setting by using cervicovaginal secretions (CVS), a process referred to as vaginal microbiota transplant (VMT).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervicovaginal secretions | Experimental | Drug: Cervicovaginal secretions, Drug: Metronidazole gel, Diagnostic Test: Screening tests, Behavioral: Activities restrictionParticipants will receive standard of care antibiotics (vaginal Metronidazole gel). After standard antibiotic treatment, participants will receive a single intravaginal dose of cervicovaginal secretions (10 mg in 1 ml total volume, 0.9 ml normal saline). |
| Saline placebo | Placebo comparator | Drug: Metronidazole gel, Diagnostic Test: Screening tests, Behavioral: Activities restriction, Other: Sterile Saline placeboParticipants will receive standard of care antibiotics (vaginal Metronidazole gel). After standard antibiotic treatment, participants will receive a single intravaginal dose of sterile saline placebo (1 ml total volume). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures.
- Generally healthy, pre-menopausal women age 18-45 years old.
- Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of long-acting progestin or continuous use of oral contraceptives.
- Free of vaginal symptoms, such as odor, discharge, or itching.
- Willing to be asked questions about personal medical, sexual, and behavioral history.
Key exclusion criteria (37 listed)
- Any history of bacterial vaginosis, recurrent yeast infection, trichomoniasis, syphilis, human papilloma virus (HPV) including genital warts, high grade pap smear, herpes, pelvic inflammatory disease, recurrent urinary tract infection, mycoplasma.
- Testing positive for HIV, Hepatitis A/B/C, syphilis, Human T-lymphotrophic Virus (HTLV)-I/II, WNV, Epstein-Barr Virus (EBV), rubella, toxoplasma gondii, Herpes Simplex Virus (HSV)-1/2, yeast or bacteria that are considered pathogenic/abnormal and/or show antibiotic resistance, chlamydia, gonorrhea, mycoplasma genitalium, trichomonas vaginalis, HPV.
- Cervicovaginal secretions (CVS) not dominated by one of the common vaginal lactobacillus species, as determined by qPCR.
- Currently pregnant or breastfeeding.
- History of gonorrhea or chlamydia within 12 months prior to screening.
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 |
|---|---|---|
| Cervicovaginal secretionsSame as arm descriptions | Drug | Cervicovaginal secretions |
| Metronidazole gel5 day course of vaginal MetroGel will be used prior to VMT intervention. | Drug | Cervicovaginal secretions, Saline placebo |
| Screening testsDiagnostic testing for a broad range of infectious pathogens in blood, vaginal swab, and urine samples, for general immunocompetence, and for potential pregnancy. | Diagnostic test | Cervicovaginal secretions, Saline placebo |
| Activities restrictionRequired abstinence from sexual intercourse, usage of insertive vaginal feminine products (i.e. Tampons, menstrual cups, sex toys), other vaginal products (cleansing products, spermicides, lubricants, hygiene powders and sprays), and avoidance of behaviors including taking baths, going swimming, sitting in hot tub, or wearing thong underwear. Sanitary napkins are acceptable. | Behavioural | Cervicovaginal secretions, Saline placebo |
| Sterile Saline placeboThis will be administered as a placebo in place of cervicovaginal secretions | Other | Saline placebo |
Primary outcome
Bacteria engraftment as assessed by ribosomal (rDNA) gene sequencing
Time frame: 28 days
Detection of Donor vaginal Lactobacillus in Recipient by 16S rDNA gene sequencing (~1% or greater relative abundance by read count)
4 secondary outcomes
Bacteria engraftment as assessed by rDNA gene sequencing
Time frame: 10 days
Bacterial communities as assessed by rDNA gene sequencing
Time frame: At screening , and then follow-up (~7 months)
Bacterial vaginosis recurrence as assessed by Amsel's criteria
Time frame: Up to 6 months after VMT procedure
Bacterial vaginosis recurrence as assessed by Nugent score
Time frame: Up to 6 months after VMT procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- 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. This study is not recruiting at the moment.
Laura Ensign, PhD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cervicovaginal secretions, Metronidazole gel and Screening tests in people with Bacterial Vaginosis, run by Johns Hopkins University.
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 21 inclusion and 37 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: withdrawn, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteria engraftment as assessed by ribosomal (rDNA) gene sequencing (time frame: 28 days). 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 3 Nov 2021.