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

Early Phase 1CompletedNCT02150655

Western University, Canada30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Vulvovaginal Candidiasis Bacterial Vaginosis

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

maintenance of healthy vaginal microbiota

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.

Time frame: 1 month

Secondary Outcomes

Reduction of environmental toxins in blood by lactobacilli