Vaginal Microbiota Transplant for Bacterial Vaginosis

(MOTIF Trial)

Overseen By Doug Kwon, MD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Douglas Kwon

Must not be taking: Immunomodulators, Systemic steroids

Disqualifiers: Cancer, Hysterectomy, Pregnancy, others

Compensation: Varies

Number of Visits: 10

Duration: 1 week

62 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

You may need to stop certain medications. You can't use immunomodulatory agents, probiotics, prebiotics, or routine oral antibiotics within 30 days before the study. Also, you can't have taken non-metronidazole antibiotics in the last 30 days.

What data supports the idea that Vaginal Microbiota Transplant for Bacterial Vaginosis is an effective treatment?

The available research shows that Vaginal Microbiota Transplant (VMT) can be an effective treatment for Bacterial Vaginosis (BV). In a study with five patients suffering from persistent BV, four experienced full long-term relief from symptoms after receiving VMT, with improvements lasting up to 21 months. This suggests that VMT can help restore a healthy balance of bacteria in the vagina, which is often disrupted in BV. In comparison, traditional antibiotic treatments for BV often lead to high recurrence rates and can worsen the imbalance of bacteria. Therefore, VMT offers a promising alternative by directly transferring healthy bacteria to the patient, potentially providing a more lasting solution. ^{1 2 3 4 5}

What safety data exists for Vaginal Microbiota Transplant for Bacterial Vaginosis?

The safety data for Vaginal Microbiota Transplant (VMT) for Bacterial Vaginosis (BV) is limited but promising. An exploratory study involving five patients with intractable BV reported no adverse effects, with four patients achieving full long-term remission. The study suggests that VMT can be safe, but further randomized, placebo-controlled clinical trials are needed to confirm its safety and efficacy. Additionally, a universal donor screening approach and FDA-approved protocols have been developed to minimize risks, ensuring the safety of VMT procedures. ^{1 2 3 4 5}

Is Vaginal Microbiota Transplant a promising treatment for Bacterial Vaginosis?

Yes, Vaginal Microbiota Transplant (VMT) is a promising treatment for Bacterial Vaginosis. It involves transferring healthy vaginal bacteria to help restore balance and improve symptoms. Studies show that VMT can lead to long-term improvement in most patients, offering a new way to treat this condition. ^{1 2 3 4 5}

Research Team

Doug Kwon, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

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:

I am a woman aged 18-50 and have not gone through menopause.

Abnormal Nugent score: > 3

Exclusion Criteria

I have had a levonorgestrel IUD inserted within the last 3 months.

I haven't used probiotics or prebiotics in the last 30 days, except for oral yogurt.

Either breastfeeding or pregnant within 24 weeks prior to study entry

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person), 1 phone call

Baseline

Baseline assessments and randomization into study groups

1 week

1 visit (in-person)

Treatment

Administration of vaginal microbiota transplant or placebo

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

6 visits (in-person)

Treatment Details

Interventions

• Vaginal Microbiota Transplant

Trial Overview 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.

Participant Groups

Group I: Vaginal microbiome transplant Active Control 2 Interventions

Women in this group will be randomized to receive two doses of vaginal fluid from a healthy donor

Group II: Saline placebo Placebo Group 2 Interventions

Women in this group will be randomized to receive two doses of sterile saline

Who Is Running the Clinical Trial?

Douglas Kwon

Lead Sponsor

Trials

1

Recruited

60+

Findings from Research

Vaginal microbiota transplantation (VMT) is being explored as a promising new treatment, similar to fecal microbiota transplantation (FMT), particularly for preventing the recurrence of bacterial vaginosis (BV).

The article highlights the medical, regulatory, and ethical challenges that need to be addressed as VMT moves towards clinical trials, emphasizing the need for careful research design and regulatory considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal Microbiota Transplantation: The Next Frontier. DeLong, K., Zulfiqar, F., Hoffmann, DE., et al.[2020]

In a small exploratory study involving five women with recurrent bacterial vaginosis, vaginal microbiome transplantation (VMT) led to full long-term remission in four patients, with follow-up lasting between 5 to 21 months.

No adverse effects were reported from the procedure, suggesting that VMT is a safe therapeutic alternative, although some patients required multiple treatments for sustained results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal microbiome transplantation in women with intractable bacterial vaginosis. Lev-Sagie, A., Goldman-Wohl, D., Cohen, Y., et al.[2021]

Vaginal microbiota transplantation (VMT) is proposed as a promising alternative treatment for bacterial vaginosis (BV), which often recurs after antibiotic therapy, but it requires strict safety protocols due to potential risks.

The study established that Lactobacillus bacteria can remain viable for over six months when stored at -80 °C, and introduced a rapid screening method using species-specific quantitative PCR to identify healthy donors with optimal vaginal microbiomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening and characterization of vaginal fluid donations for vaginal microbiota transplantation. Yockey, LJ., Hussain, FA., Bergerat, A., et al.[2023]

Fecal microbiota transplant (FMT) has shown success in treating recurrent Clostridioides difficile infections, leading to interest in vaginal microbiota transplant (VMT) as a potential therapy for conditions related to microbial imbalance, particularly bacterial vaginosis (BV).

A pilot study involving 20 women established a universal donor screening approach to identify optimal donors with healthy vaginal microbiota, which is crucial for ensuring safety and efficacy in future VMT clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptual Design of a Universal Donor Screening Approach for Vaginal Microbiota Transplant. DeLong, K., Bensouda, S., Zulfiqar, F., et al.[2020]

Conventional antibiotic treatments for bacterial vaginosis (BV) often worsen microbial imbalances and lead to drug resistance, resulting in low cure rates and high recurrence rates.

Vaginal microbiota transplantation (VMT) offers a promising alternative by transferring healthy vaginal microbiota to patients, aiming to restore vaginal health more effectively than traditional antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vaginal microbiota transplantation for treatment of bacterial vaginosis: a review]. Wei, K., Chen, T.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Vaginal Microbiota Transplantation: The Next Frontier. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Vaginal microbiome transplantation in women with intractable bacterial vaginosis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Screening and characterization of vaginal fluid donations for vaginal microbiota transplantation. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Conceptual Design of a Universal Donor Screening Approach for Vaginal Microbiota Transplant. [2020]

5. China pubmed.ncbi.nlm.nih.gov

[Vaginal microbiota transplantation for treatment of bacterial vaginosis: a review]. [2021]