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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02150655
Other study ID # 102886
Secondary ID
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


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
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