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Bacterial vaginosis (BV) is under-reported, misdiagnosed and inappropriately treated in Nigeria. Treatment option rely on antibiotics that eliminates both good and pathogenic bacteria, with gross impact on the gut and vaginal microbiome. Our primary objective in this study is to determine the effects of Lactobacillus on the gut and vagina when taken orally.
Antibiotics reduces in considerable proportion both the healthy bacteria especially Lactobacilli and those associated with BV, thus the vaginal microecology and gut is adversely affected. It is widely acknowledged that Lactobacilli and other genera that produces some metabolites such as lactic acid, contributes to vaginal health by maintaining the low pH of the vagina.
The objectives of this study are three folds, first to determine the effects before and after 14 days oral feeding of Lactobacillus pentosus KCA1 on the vaginal and gut microbiota compositions of women diagnosed with BV. Second to measure the level of two proinflammatory cytokines IL-1 beta and IL-6 before and after KCA1 consumption and third to determine in silico, the relative abundance of microbial genes involved in metabolic functions using the 16S rRNA datasets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gut and vaginal sample collection | No Intervention | Gut and vaginal samples were collected for Nugent score, and 16S rRNA metagenomics communities. | |
| Gut and Vaginal sample after Lactobacillus | Experimental | Seven women diagnosed with BV by Nugent score (7-10) provided vaginal and gut sample after 14 days oral intake of 3 grams (2.5X108 cfu/g) of Lactobacillus pentosus KCA1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus pentosus KCA1 | Other | Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nugent score | Gram stain microscopy for different bacterial morphotypes | 14 days |
| Gut and Vaginal microbiota | Relative abundance of bacterial communities before and after Lactobacillus pentosus KCA1 | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 Proinflammatory cytokine | Levels of Interleukin-6 with Enzyme-Linked Immunosorbent assay (ELISA) | 14 days |
| IL-1beta Proinflammatory cytokine | Level of Interleukin-I beta with Enzyme-Linked Immunosorbent assay (ELISA) |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant, use of antibiotic medication, declined informed consent, menstruating and those that used douches, sprays, spermicides in the last 48 hours
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nnamdi Azikiwe University Teaching Hospital | Nnewi | Anambra | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23527145 | Background | Anukam KC, Macklaim JM, Gloor GB, Reid G, Boekhorst J, Renckens B, van Hijum SA, Siezen RJ. Genome sequence of Lactobacillus pentosus KCA1: vaginal isolate from a healthy premenopausal woman. PLoS One. 2013;8(3):e59239. doi: 10.1371/journal.pone.0059239. Epub 2013 Mar 19. |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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In this case each participant served as control as we collected sample before and after intervention
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This is an open label study
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| 14 days |
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |