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 |
|---|---|
| •L. crispatus dominance – The colonization outcome is a direct comparison between the arms at 3 weeks after completion of LBP. Colonization is defined as > 50% relative abundance of L. crispatus by metagenomics. ;•Safety Analysis – The number of reported adverse events deemed related to or potentially related to the study product will be tallied for each category of severity and compared between active arm and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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