drugset / Trial / NCT07566754
MOTIF@FRESH: Modifying Organisms Transvaginally in Females @ FRESH
Phase 2
Not yet recruiting
75 enrolled
Douglas Kwon
Bill and Melinda Gates Foundation · collabMassachusetts General Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-09
- Primary completion
- 2027-05
- Completion
- 2028-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metronidazole | Small molecule | 400 mg | Oral |