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

Bacterial Vaginosis Clinical Trial

— RVMM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150655
• Other study ID #: 102886
• Status: Completed
• Phase: Phase 0
• First received: July 4, 2013
• Last updated: May 29, 2014
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaRwanda: Ministry of Education, University of Kigali Teaching Hospital (CHUK) Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Candidiasis
• Candidiasis, Vulvovaginal
• Vaginosis, Bacterial
• Vulvovaginal Candidiasis

Intervention

Biological:
• Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules

• Placebo

Locations

Country	Name	City	State
Rwanda	Nyamata District Hospital	Nyamata	East Province

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month	No
Secondary	Reduction of environmental toxins in blood by lactobacilli		1 month	No