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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 oral capsules |
|
| Placebo | Placebo Comparator | Sugar pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of environmental toxins in blood by lactobacilli | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregor Dr Reid, PhD | Western University, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nyamata District Hospital | Nyamata | East Province | Rwanda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29912913 | Derived | 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. |
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| Biological |
|
|
| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014848 | Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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