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

Early Phase 1

Completed

• Conditions: Vulvovaginal Candidiasis; Bacterial Vaginosis
• Interventions: Biological: Placebo; Biological: Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules

• Registration Number: NCT02150655
• Lead Sponsor: Western University, Canada

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-07-04
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-29
• Last Update Submitted: 2014-05-29
• Study First Posted: 2014-05-30
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Sugar pill
Probiotic	Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules	Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 oral capsules

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Reduction of environmental toxins in blood by lactobacilli	1 month

Trial Locations

Locations (1)

Nyamata District Hospital; 🇷🇼 Nyamata, East Province, Rwanda