Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women (RVMM)
Primary Purpose
Vulvovaginal Candidiasis, Bacterial Vaginosis
Status
Completed
Phase
Early Phase 1
Locations
Rwanda
Study Type
Interventional
Intervention
Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Vulvovaginal Candidiasis
Eligibility Criteria
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.
Sites / Locations
- Nyamata District Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 oral capsules
Sugar pill
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Reduction of environmental toxins in blood by lactobacilli
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02150655
Brief Title
Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women
Acronym
RVMM
Official Title
Pilot Study Investigating Bacteria (Microbiota), Their By-products (Metabolome) and Environmental Toxins in Relation to Reproductive Health in Rwandan Women.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis, Bacterial Vaginosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 oral capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sugar pill
Intervention Type
Biological
Intervention Name(s)
Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Primary Outcome Measure Information:
Title
maintenance of healthy vaginal microbiota
Description
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 Outcome Measure Information:
Title
Reduction of environmental toxins in blood by lactobacilli
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor Dr Reid, PhD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nyamata District Hospital
City
Nyamata
State/Province
East Province
Country
Rwanda
12. IPD Sharing Statement
Citations:
PubMed Identifier
29912913
Citation
McMillan A, Rulisa S, Gloor GB, Macklaim JM, Sumarah M, Reid G. Pilot assessment of probiotics for pregnant women in Rwanda. PLoS One. 2018 Jun 18;13(6):e0195081. doi: 10.1371/journal.pone.0195081. eCollection 2018.
Results Reference
derived
Learn more about this trial
Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women
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