Bacterial Vaginoses
Conditions
Keywords
Lactobacillus, Microbiota, Nigerian women, Gut, Vagina, 16S rRNA, Sequencing, Metagenomics
Brief summary
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.
Detailed description
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.
Interventions
OTHERLactobacillus pentosus KCA1
Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days
Sponsors
Nnamdi Azikiwe University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This is an open label study
Intervention model description
In this case each participant served as control as we collected sample before and after intervention
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Not on antibiotic therapy within the last one month * Not menstruating at the time of inclusion.
Exclusion criteria
Pregnant, use of antibiotic medication, declined informed consent, menstruating and those that used douches, sprays, spermicides in the last 48 hours \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nugent score | 14 days | Gram stain microscopy for different bacterial morphotypes |
| Gut and Vaginal microbiota | 14 days | Relative abundance of bacterial communities before and after Lactobacillus pentosus KCA1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 Proinflammatory cytokine | 14 days | Levels of Interleukin-6 with Enzyme-Linked Immunosorbent assay (ELISA) |
| IL-1beta Proinflammatory cytokine | 14 days | Level of Interleukin-I beta with Enzyme-Linked Immunosorbent assay (ELISA) |
Countries
Nigeria
Outcome results
None listed