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NOT YET RECRUITING
NCT07566754
PHASE2

MOTIF@FRESH: Modifying Organisms Transvaginally in Females @ FRESH

Sponsor: Douglas Kwon

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-09

Completion Date

2028-02

Last Updated

2026-05-18

Healthy Volunteers

No

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

Locations (1)

FRESH Clinic

Durban, South Africa