This is a phase IIa clinical trial in women with bacterial vaginosis. This study will determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found in normal vaginal flora.
Phase IIa randomized, double blind, placebo-controlled, clinical trial of LACTIN-V at 2 x 10\^9 cfu/dose versus placebo, administered vaginally with a pre-filled applicator once daily for five consecutive days followed by a weekly dose over 2 additional weeks after an initial standardized antibiotic treatment with 0.75% topical metronidazole (MetroGel). A single site will enroll 40 participants (30 randomized to LACTIN-V and 10 to placebo). Colonization rate of Lactobacillus crispatus CTV 05 will be assessed with culture and rep-PCR. Safety will be determined by comparing the incidence of adverse events and serious adverse events in the LACTIN-V and placebo groups as determined by clinical symptoms, physical examination, pelvic examination with colposcopy and laboratory measurements. Tolerability will be measured by percentage of subjects who discontinue study product use due to overt adverse events and percentage of subjects who adhere to complete dosing schedule. Acceptability will be assessed via a standardized questionnaire and focus group discussions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
40
Vaginal application of single-use applicators pre-filled with LACTIN-V (Formulation 1) at 2 x 10\^9 cfu/dose or placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Vaginal application of single-use applicators pre-filled with placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
San Francisco General Hospital (SFGH), University of California, San Francisco (UCSF)
San Francisco, California, United States
To evaluate the vaginal colonization efficiency of L. crispatus CTV-05 after vaginal administration of LACTIN-V at 2 x 10^9 cfu/dose (600 mg) daily for 5 days followed by weekly applications over 2 additional weeks
Time frame: 4 weeks after intervention
To evaluate the safety of L. crispatus, LACTIN-V in otherwise healthy pre-menopausal women with BV, immediately after standardized antibiotic treatment with 0.75% topical metronidazole
Time frame: 10 days and 4 weeks after intervention
To evaluate the tolerability and acceptability of LACTIN-V as a powder in a pre-filled applicator
Time frame: 4 weeks after intervention
To evaluate and compare vaginal flora by Gram stain before and after receipt of LACTIN-V or placebo.
Time frame: 10 days and 4 weeks after intervention
To identify and compare bacteria colonizing the vagina at screening in women with bacterial vaginosis and after antibiotic and probiotic treatment.
Time frame: Before intervention and 4 weeks after intervention
To measure and compare the 4 week cure rate of BV after receipt of MetroGel in women who receive LACTIN-V or placebo.
Time frame: 4 weeks after intervention
To measure the rate of vaginal colonization by Candida sp. and symptomatic vaginal candidiasis after receiving LACTIN-V or placebo
Time frame: 4 weeks after intervention
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