MOTIF@FRESH: Modifying Organisms Transvaginally in Females @ FRESH

ConditionRecurrent Bacterial Vaginosis (BV)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-25

SponsorDouglas Kwon

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

Vaginal Microbiome Transplantation (VMT)
oral metronidazole
Sterile saline solution

Treatment groups

75 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Douglas Kwon

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Massachusetts General Hospital

Collaborator

Bill and Melinda Gates Foundation

Collaborator

Source ClinicalTrials.gov