Health TrialsbyHealthPanel

Vaginal Microbiota Transplant

ConditionRecurrent Bacterial Vaginosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorDouglas Kwon

About this trial

This is a randomized trial of vaginal microbiome transplant vs. saline placebo to restore a Lactobacillus dominant vaginal microbial community in women with recurrent bacterial vaginosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Premenopausal women, 18- 50 years old

Abnormal Nugent score: > 3

History of recurrent bacterial vaginosis (BV) (3 or more documented episodes in past 12 months)

Condoms (male or female), with or without a spermicidal agent

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) within the 30 days prior to the procedure.

Allergy to metronidazole

Use of investigational therapies or investigational vaccines within 90 days prior to study entry

Use of any immunomodulatory agents within 30 days prior to study enrollment. Subject taking any of the following medications: systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g. local injection of interferon alpha for treatment of HPV is permitted) or systemic chemotherapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vaginal microbiome transplant

    Biological/Vaccine

    Vaginal fluid from healthy donors

  • Oral Metronidazole

    Drug

    500mg oral metronidazole twice daily for 7 days

  • Sterile saline

    Other intervention

    700 uL of sterile saline placed in the vagina as a placebo intervention.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Vaginal microbiome transplantActive comparator 2 interventions
Group B: Saline placeboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Presence of Lactobacillus crispatus-dominant microbiome

Lactobacillus crispatus dominant = relative abundance of Lactobacillus crispatus in the vaginal microbial community \> 50%

Time frame
5 weeks after intervention

Secondary outcomes

1

Presence of Lactobacillus-dominant microbiome

Characterization of the vaginal microbial community using 16S rRNA sequencing

Time frame
1, 3, 5, 7 weeks, 4 and 6 months after intervention
2

Number of women reporting adverse events

Report of adverse events

Time frame
1, 3, 5, 7 weeks, 4 and 6 months after intervention
3

Presence of Lactobacillus crispatus-dominant microbiome

Characterization of the vaginal microbial community using 16S rRNA sequencing

Time frame
1, 3, 7 weeks, 4 and 6 months 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

Source ClinicalTrials.gov
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