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Microbiome Therapy

Vaginal Microbiota Transplant for Bacterial Vaginosis (MOTIF Trial)

Phase 1 & 2
Recruiting
Led By Doug Kwon, MD, PhD
Research Sponsored by Douglas Kwon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenopausal women, 18- 50 years old
Hormonal contraceptive (including oral pills, vaginal ring, implant, injection)
Must not have
Insertion of levonorgestrel-containing IUD within 3 months 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 5, 7 weeks, 4 and 6 months after intervention

Summary

This trial is testing whether or not a vaginal microbiome transplant can help women with recurrent bacterial vaginosis by restoring a Lactobacillus dominant vaginal microbial community.

Who is the study for?
This trial is for premenopausal women aged 18-50 with recurrent bacterial vaginosis, who have had at least three episodes in the past year. Participants must not be pregnant or breastfeeding, should agree to use effective contraception if sexually active, and cannot have a BMI over 40 or serious health conditions like heart disease.
What is being tested?
The study is testing whether a vaginal microbiome transplant can establish a healthy Lactobacillus-dominated microbial community compared to a saline placebo. It's for those who haven't responded well to traditional treatments and involves random assignment into treatment groups.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort or infection from the transplant procedure. Metronidazole can cause nausea, headache, loss of appetite, and metallic taste in mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18-50 and have not gone through menopause.
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I am currently using a form of hormonal birth control.
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I have had bacterial vaginosis 3 or more times in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a levonorgestrel IUD inserted within the last 3 months.
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I have not used any immune system affecting drugs or systemic chemotherapy in the last 30 days.
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I have had significant issues with my reproductive organs, including cancer or surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 7 weeks, 4 and 6 months after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 7 weeks, 4 and 6 months after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Number of women reporting adverse events
Presence of Lactobacillus-dominant microbiome

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Vaginal microbiome transplantActive Control2 Interventions
Women in this group will be randomized to receive two doses of vaginal fluid from a healthy donor
Group II: Saline placeboPlacebo Group2 Interventions
Women in this group will be randomized to receive two doses of sterile saline

Find a Location

Who is running the clinical trial?

Douglas KwonLead Sponsor
Doug Kwon, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Vaginal Microbiota Transplant (Microbiome Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04046900 — Phase 1 & 2
Bacterial Vaginosis Research Study Groups: Saline placebo, Vaginal microbiome transplant
Bacterial Vaginosis Clinical Trial 2023: Vaginal Microbiota Transplant Highlights & Side Effects. Trial Name: NCT04046900 — Phase 1 & 2
Vaginal Microbiota Transplant (Microbiome Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04046900 — Phase 1 & 2
~25 spots leftby Oct 2025
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