Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis

Conditions
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Bacterial Vaginoses

Intervention / Treatment
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* Other: Lactobacillus pentosus KCA1


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: In this case each participant served as control as we collected sample before and after intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Gut and vaginal sample collection<br>Gut and vaginal samples were collected for Nugent score, and 16S rRNA metagenomics communities. | |
| Experimental: Gut and Vaginal sample after Lactobacillus<br>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 | Other: Lactobacillus pentosus KCA1<br>* Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut, Lactobacillus, Microbiota, Nigerian women, Vagina, 16S rRNA, Sequencing, Metagenomics