drugset / Trial / NCT02150655

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

NCT02150655 ↗

Phase 0 Completed 30 enrolled Western University, Canada
RandomizedParallel-groupQuadruple-blindBasic science

Summary

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.

Timeline

Start
2012-09
Primary completion
2013-09
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactobacillus reuteri RC-14 Other / unclassified — Oral
Subject Lactobacillus rhamnosus GR-1 Other / unclassified — Oral