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OpenTrials
Completed

NCT Number: NCT04329338

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

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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Key information

Conditions

Bacterial Vaginoses Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nnamdi Azikiwe University Teaching Hospital

Nnewi, Anambra, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Lactobacillus pentosus KCA1

Other

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

Primary outcomes

  1. Nugent score

    Time frame: 14 days

    Gram stain microscopy for different bacterial morphotypes

  2. Gut and Vaginal microbiota

    Time frame: 14 days

    Relative abundance of bacterial communities before and after Lactobacillus pentosus KCA1

Secondary outcomes

  1. IL-6 Proinflammatory cytokine

    Time frame: 14 days

    Levels of Interleukin-6 with Enzyme-Linked Immunosorbent assay (ELISA)

  2. IL-1beta Proinflammatory cytokine

    Time frame: 14 days

    Level of Interleukin-I beta with Enzyme-Linked Immunosorbent assay (ELISA)

Sponsors and collaborators

Lead sponsor

Nnamdi Azikiwe University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2020
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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