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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2019-12-10

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.

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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.

Conditions

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Bacterial Vaginoses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

In this case each participant served as control as we collected sample before and after intervention

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

This is an open label study

Study Groups

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Gut and vaginal sample collection

Gut and vaginal samples were collected for Nugent score, and 16S rRNA metagenomics communities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Gut and Vaginal sample after Lactobacillus

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

Group Type EXPERIMENTAL

Lactobacillus pentosus KCA1

Intervention Type OTHER

Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days

Interventions

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Lactobacillus pentosus KCA1

Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days

Intervention Type OTHER

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

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Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes