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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Vaginal Microbiome Transplantation (VMT)

    Biological/Vaccine

    Vaginal fluid from healthy donors

  • oral metronidazole

    Drug

    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.

  • Sterile saline solution

    Other intervention

    1mL of sterile saline solution

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Recipient: PlaceboPlacebo comparator 2 interventions
Group B: Recipient: Vaginal Microbiome Transplantation (VMT)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Evaluate the safety of VMT

The primary outcome of the study is to evaluate if VMT increases the proportion of women with a Lactobacillus crispatus-dominant microbiota at any time within the 4 weeks after the first dose as measured by sequencing of the microbial community where Lactobacillus crispatus make up \> 50% of detected microbes.

Time frame
for 23 weeks after intervention

Secondary outcomes

1

Determine whether VMT will result in a durable change in vaginal microbiota

Secondary outcome will measure Lactobacillus crispatus dominance across follow-up weeks. The hypothesis is that antibiotic plus VMT therapy will increase the proportion of women with a Lactobacillus crispatus-dominant microbiota from 5-10% to 50-60%. The safety, toxicity, and tolerability of VMT will also be assessed via a) follow up pelvic assessments to assess for rash, irritation or infection calls, b) patient symptom questionnaires to assess self-reported symptoms of vulvovaginal discomfort, and c) adverse event reporting.

Time frame
2, 12, and 24 weeks after intervention
2

Characterize the host clinical and subclinical mucosal inflammatory response before and after VMT

Additional secondary, exploratory analyses will be done to evaluate mechanisms for increased Lactobacillus prevalence, or lack thereof. This will include measuring proportions of individual Lactobacillus species (e.g., L. crispatus, L. iners, L. jensenii, L. gasseri), assessing vaginal microbial community type, microbial community diversity measures, individual taxa associated with treatment group, and host mucosal inflammatory immune response. (e.g., vaginal concentration of IL1beta, IL1alpha, IL1RA, IL6, IL8, TNFa, IFNg)

Time frame
24 weeks after intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Douglas Kwon

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Massachusetts General Hospital

Collaborator

Bill and Melinda Gates Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: