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MOTIF@FRESH: Modifying Organisms Transvaginally in Females @ FRESH

NCT07566754 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Bacterial Vaginosis (BV)

Interventions

BIOLOGICAL

Vaginal Microbiome Transplantation (VMT)

Vaginal fluid from healthy donors

DRUG

oral metronidazole

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.

OTHER

Sterile saline solution

1mL of sterile saline solution

Sponsors & Collaborators

Principal Investigators

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-05-31
Completion
2028-02-29

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566754 on ClinicalTrials.gov