Pilot Study Investigating Bacteria (Microbiota), Their By-products (Metabolome) and Environmental Toxins in Relation to Reproductive Health in Rwandan Women. (RVMM)

NCT02150655 EARLY_PHASE1 COMPLETED

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.

Details

Lead sponsor	Western University, Canada
Phase	EARLY_PHASE1
Status	COMPLETED
Enrolment	30
Start date	2012-09
Completion	2013-12

Conditions

• Vulvovaginal Candidiasis
• Bacterial Vaginosis

Interventions

• Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules
• Placebo

Primary outcomes

• maintenance of healthy vaginal microbiota — 1 month
  The change in relative abundance of healthy lactobacilli and species associated with bacterial vaginosis after one month probiotic intervention will be assessed using 16S rRNA gene sequencing.

Countries

Rwanda