MOTIF@FRESH: Modifying Organisms Transvaginally in Females @ FRESH
South Africa75 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range18 Years – 25 Years
SexFEMALE
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Inclusion Criteria:
* Premenopausal females between 18 to 25 years of age who are enrolled in the FRESH study
* Nugent score ≥ 4
* Confirmation of use of effective contraceptive method by all study recipient participants (referred to as recipients) of child-bearing potential, which includes use of at least one of the following: Hormonal method, such as birth control pills, patches, injections, vaginal rings, or implants; Barrier method, such as a condom or diaphragm used with a spermicide (a foam, cream, or gel that kills sperm); Intrauterine device (IUD) - non-levonorgestrel containing
* Ability and willingness to give written informed consent.
Exclusion Criteria:
* History of clinically significant vaginal, cervical, or uterine disease including but not limited to cancer of the female reproductive tract, prior hysterectomy, high grade cervical dysplasia (CIN III), or diagnosed with cervicovaginal infection (with the exception of bacterial vaginosis or yeast) within the 30 days prior to the procedure
* Allergy to metronidazole
* Use of investigational therapies or investigational vaccines within 90 days prior to study screening
* Has not received the HPV vaccine and is not willing to be vaccinated
* Metabolic syndrome, e.g. diabetes, pre-diabetes, glucose intolerance
* Use of any immunomodulatory agents within 30 days prior to study enrollment
* Participants taking any of the following medications: systemic steroids (inhaled or nasal steroid therapy is permitted), interle…