NCT02150655

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Western University, Canada · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vulvovaginal Candidiasis
• Bacterial Vaginosis

Interventions

Type	Name	Description
BIOLOGICAL	Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules
BIOLOGICAL	Placebo

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2014-05-30
• Last updated: 2014-05-30

Locations

1 site across 1 country: Rwanda