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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02150655 |
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Date of registration:
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04/07/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women
RVMM |
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Scientific title:
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Pilot Study Investigating Bacteria (Microbiota), Their By-products (Metabolome) and Environmental Toxins in Relation to Reproductive Health in Rwandan Women. |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02150655 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Phase:
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Phase 0
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Countries of recruitment
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Rwanda
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Contacts
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Name:
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Gregor Dr Reid, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Western Ontario, Canada |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Bacterial Vaginosis
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Vulvovaginal Candidiasis
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Intervention(s)
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Biological: Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules
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Biological: Placebo
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Primary Outcome(s)
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maintenance of healthy vaginal microbiota
[Time Frame: 1 month]
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Secondary Outcome(s)
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Reduction of environmental toxins in blood by lactobacilli
[Time Frame: 1 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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