MOTIF@FRESH: Modifying Organisms Transvaginally in Females @ FRESH
MOTIF@FRESH
MOTIF@FRESH
Sponsor study identifier
interventional
75
1 country
1
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The MOTIF@ FRESH trial will assess the safety and efficacy of "vaginal microbiome transplantation" (VMT). Healthy females will be enrolled to donate vaginal fluid which will be processed and transplanted in females with a history of recurrent bacterial vaginosis (BV), treated with antibiotics.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 21, 2026
Actual (reported)May 5, 2026
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Evaluate the safety of VMT
The primary outcome of the study is to evaluate if VMT increases the proportion of women with a Lactobacillus crispatus-dominant microbiota at any time within the 4 weeks after the first dose as measured by sequencing of the microbial community where Lactobacillus crispatus make up \> 50% of detected microbes.
for 23 weeks after intervention
Determine whether VMT will result in a durable change in vaginal microbiota
2, 12, and 24 weeks after intervention
Characterize the host clinical and subclinical mucosal inflammatory response before and after VMT
24 weeks after intervention
Women in this group will be randomized to receive three doses of sterile saline solution after completing a full course of MTZ
Women in this group will be randomized to receive three doses of VMT after completing a full course of MTZ
Vaginal fluid from healthy donors
Metronidazole 400 mg PO every 12 hours for 7 days is the concomitant medication. This antibiotic course is the standard Bacterial Vaginosis (BV) treatment which effectively eliminates microbes associated with BV for a limited time.
FRESH Clinic
Durban, South Africa
Douglas S Kwon, MD, PhD
Ragon Institute of MGB, MIT, and Harvard
Caroline Mitchell, MD, MPH
Massachusetts General Hospital
Krista Dong, MD
Ragon Institute of MGB, MIT, and Harvard
First Submitted
April 21, 2026
First Posted
May 5, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 18, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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