Bacterial Vaginosis Urological and Genital Diseases
Conditions
Interventions
Sponsors
Centre for AIDS Programme of Research in South Africa
Caroline Mitchell
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Pre-menopausal women aged 18– 40 years old • BV diagnosed by a Nugent score of =7 • Not pregnant at screening/enrolment visit, and unlikely to have an early pregnancy per clinician’s assessment of last menstrual period and recent sexual activity. • If of reproductive potential, agrees to use a reliable form of contraception for at least 14 days prior to enrolment and to continue for at least the first 3 months of the study. Except for the Copper intra-uterine device (IUD) • HIV negative based on 4th generation antigen/antibody rapid HIV testing done at the screening visit • Willing and able to provide written informed consent • Willing and able to attend study visits and comply with study procedures
Exclusion criteria
Exclusion criteria: • Diagnosed with a sexually transmitted infection (STI) within the 30 days prior or at the screening/enrolment visit • Use of antibiotics in the past 30 days • Use of probiotics, prebiotics or synbiotics (supplements and products, oral or vaginal) within past 30 days • Vaginal cleansing practices or use of a vaginally inserted product in the past 30 days • Currently participating in another study of an investigational product • History of clinically significant vaginal, cervical, or uterine disease including but not limited to: cancer of the female reproductive tract • Use of a Copper IUD for contraception • Clinically significant acute or chronic medical condition or other circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study or jeopardises the safety or rights of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Safety of LC115 and the pre-treatments (BV treatment) (rates of AE and SAEs) • Vaginal microbiome dominance by L. crispatus (i.e. > 50% relative abundance) by metagenomic sequencing at V6 (3 weeks after LBP treatment) without the use of oral metronidazole in the 3 weeks after LBP treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes • Kinetics of colonization with each of the strains contained in LC115 throughout the study. • Relative abundance of Lactobacillus iners and total Lactobacillus post BV treatment, post LBP and over time during follow-up. • Change in absolute bacterial load by qPCR after BV treatment and after LBP treatment. • Change in diversity and composition of the vaginal microbial community post BV treatment, post LBP and over time during follow-up. • Extended follow up to 12 months to assess durability of response for both the primary and secondary outcomes. • Participant acceptability and tolerability of LC115. Exploratory outcome • Exploratory data describing the relationship and degree of overlap between rectal and vaginal microbiota, including identification of shared taxa that may inform understanding of microbial reservoirs and BV recurrence. | — |
Countries
South Africa
Contacts
Public ContactTanuja Gengiah
CAPRISA Co Investigator and CAPRISA Pharmacist Head of Pharmacy
Outcome results
None listed