Urological and Genital Diseases Bacterial vaginosis
Conditions
Interventions
Women with BV at screening received antibiotics alone (standard of care)
Healthy women without BV but received vagina Ecovag supplement
Women with BV at screening received antibiotics and Ecovag supplement
Sponsors
Perinatal HIV Research Unit
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Females. 18-40 years. Pre-menopausal on menstrual history. Read and understand English. Provide voluntary informed consent. HIV-negative. Intact genital tract. Use Depot Medroxyprogesterone Acetate or norethisterone enanthate injectable contraception for at least 7 days by visit 1 (day 0) Willing to receive HIV testing and counselling
Exclusion criteria
Exclusion criteria: Positive for pregnancy test or breastfeeding at study entry. Infected with C. trachomatis or T. vaginalis. History of abnormality on Pap test. Currently using oral contraceptive. Menstruating on enrollment. Did not have sexual debut. Treated with antibiotics within eight weeks of study enrollment. Using oral or vaginal probiotic capsules within eight weeks of enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women colonized by the administered EcoVag¿ Lactobacilli using cultivation and real-time PCR. | — |
Secondary
| Measure | Time frame |
|---|---|
| the proportion of women who are cured from BV and the time from treatment to relapse (if any). | — |
Countries
South Africa
Contacts
Public ContactKennedy Otwombe
Outcome results
None listed