Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women (RVMM)

Western University, Canada

Status and phase

Completed

Early Phase 1

Conditions

Vulvovaginal Candidiasis

Bacterial Vaginosis

Treatments

Biological: Placebo

Biological: Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT02150655

102886

Details and patient eligibility

About

The overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a healthy state and lower environmental toxins will be completed.

Enrollment

30 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Pregnant women between the ages of 18 and 55.

Exclusion criteria

*Current infection of gonorrhoea, *Chlamydia, genital warts, *active genital herpes lesions, *active syphilis; *urinary tract infection including pyelonephritis (an ascending urinary tract infection); *receiving drug therapy that may affect the vaginal flora; *had unprotected sexual intercourse (vaginal or oral) within the past 48 hours; *have used a vaginal douche, genital deodorant, or genital wipe products in the past 48 hours; *have taken any 'acidophilus' 'bifidobacteria' or probiotic health food supplements in the past 48 hours; *are menstruating at time of clinical visit.