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Vaginal Microbiota Transplant (MOTIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04046900
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : March 14, 2023
Information provided by (Responsible Party):
Douglas Kwon, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Recurrent Bacterial Vaginosis Biological: Vaginal microbiome transplant Drug: Oral Metronidazole Other: Sterile saline Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Participants will be randomized 1:1 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 126 people, which will be analyzed separately.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vaginal Microbiota Transplant to Promote Lactobacillus-dominant Cervicovaginal Communities
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Active Comparator: Vaginal microbiome transplant
Women in this group will be randomized to receive two doses of vaginal fluid from a healthy donor
Biological: Vaginal microbiome transplant
Vaginal fluid from healthy donors

Drug: Oral Metronidazole
500mg oral metronidazole twice daily for 7 days

Placebo Comparator: Saline placebo
Women in this group will be randomized to receive two doses of sterile saline
Drug: Oral Metronidazole
500mg oral metronidazole twice daily for 7 days

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

Primary Outcome Measures :
  1. Presence of Lactobacillus-dominant microbiome [ Time Frame: 5 weeks after intervention ]
    Lactobacillus dominant = relative abundance of Lactobacillus in the vaginal microbial community > 50%

Secondary Outcome Measures :
  1. Presence of Lactobacillus-dominant microbiome [ Time Frame: 1, 3, 7 weeks, 4 and 6 months after intervention ]
    Characterization of the vaginal microbial community using 16S rRNA sequencing

  2. Number of women reporting adverse events [ Time Frame: 1, 3, 5, 7 weeks, 4 and 6 months after intervention ]
    Report of adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04046900

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Contact: Doug Kwon, MD, PhD 857-268-7009

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Caroline Mitchell, MD, MPH    617-724-2182   
Principal Investigator: Caroline Mitchell, MD, MPH         
Sponsors and Collaborators
Douglas Kwon
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Principal Investigator: Doug Kwon, MD, PhD Massachusetts General Hospital
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Responsible Party: Douglas Kwon, Principle Investigator, Massachusetts General Hospital Identifier: NCT04046900    
Other Study ID Numbers: 2019P001543
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: March 14, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents