A Phase 2 interventional study of Vaginal Microbiome Transplantation (VMT) and oral metronidazole in Recurrent Bacterial Vaginosis (BV), sponsored by Douglas Kwon. Not yet recruiting at 1 site in South Africa. Open to female participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Douglas Kwon · Phase 2, Interventional, and Treatment
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.
The proposed randomized, double-blinded, placebo-controlled trial is to evaluate the safety of vaginal microbiota transplantation (VMT) in women with recurrent bacterial vaginosis (BV). The study is based in South Africa, at the FRESH (Females Rising through Education, Support, and Health) Clinical Research Site (CRS) located in the Umlazi Township of Durban. The aim of the trial is to assess the ability of antibiotic treatment plus VMT to establish a Lactobacillus-dominant vaginal community. The underlying hypothesis is that the VMT will lead to less inflammation and higher prevalence of vaginal Lactobacillus compared to antibiotics alone. The transplant material will be vaginal fluid collected from healthy donors (also known as Donors) using a disposable menstrual cup.
Donors are defined as participants with Nugent scores \<4. Over a 16-week period, donors will provide vaginal fluid via softcups (referred to as "donations"). All donations will undergo extensive testing for sexually transmitted infections (STIs) and other infections. Donations that test negative for specified infections will be processed to generate vaginal microbial transplantation (VMT) doses for recipients.
Recipients are defined as participants with Nugent scores ≥4. Because the HPV vaccine is not routinely administered in South Africa, all recipients without documented proof of prior HPV vaccination will receive the HPV vaccine at least 30 days prior to the intervention. The intervention includes the standard of care for bacterial vaginosis in both the U.S. and South Africa: oral metronidazole (MTZ), administered twice daily for seven days. Following completion of the MTZ course, recipients will receive three VMT doses administered over approximately 1.5 weeks. Recipients will be randomized in a 2:1 ratio to receive either VMT or placebo and will be followed for six months post-intervention.
Exclusion Criteria:
Use of probiotics and prebiotics (supplements and products, oral or vaginal) within 30 days of the study
- NOTE: Oral yogurt with live cultures and fermented foods are allowed.
Positive for any of the STIs listed below or on treatment for any of them.
Women in this group will be randomized to receive three doses of sterile saline solution after completing a full course of MTZ
Drug: oral metronidazole · Other: Sterile saline solution
Women in this group will be randomized to receive three doses of VMT after completing a full course of MTZ
Biological: Vaginal Microbiome Transplantation (VMT) · Drug: oral metronidazole
Vaginal fluid from healthy donors
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.
1mL of sterile saline solution
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
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
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
Plan to share: Undecided
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Douglas Kwon