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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 5, 7 weeks, 4 and 6 months after intervention
Awards & highlights

MOTIF Trial 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.Check my eligibility
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.See study design
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.

MOTIF Trial 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.

MOTIF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Number of women reporting adverse events
Presence of Lactobacillus-dominant microbiome

MOTIF 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are minors eligible to participate in this scientific research?

"For this clinical trial, participants must be between the age of majority and 50 years old."

Answered by AI

For what medical ailments is vaginal microbiome transplant a viable option?

"Historically, vaginal microbiome transplants have been used to counter bacteria. Nonetheless, they are also effective at treating entamoeba histolytica, bacterial septicemia, and vaginitis."

Answered by AI

Are there any current opportunities to join this scientific exploration?

"Affirmative. The particulars of this medical trial, first published on April 22nd 2021 and recently modified on November 18th 2021, are available to view online at clinicaltrials.gov. This study is currently seeking 134 participants from a single location for enrollment in the trial."

Answered by AI

Who is most likely to be recruited for this medical experiment?

"Those who meet the requirements of this trial must have bacterial vaginosis, be between 18 and 50 years old, and may join a pool of 134 other participants."

Answered by AI

What is the cap on enrollment for this clinical experiment?

"Affirmative, clinicaltrials.gov has evidence that this research project is in the process of enrolling patients. Initially posted on April 22nd 2021, it was last updated November 18th 2021 and requires 134 participants from a single location to complete recruitment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vaginal Microbiota Transplant
Douglas Kwon 2021. "Vaginal Microbiota Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04046900.
~22 spots leftby Dec 2024
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