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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginoses
• Intervention / Treatment: Other: Lactobacillus pentosus KCA1

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Anambra
    • Nnewi, Anambra, Nigeria
      • Nnamdi Azikiwe University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nnamdi Azikiwe University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): September 20, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Microbiota; Sequencing; Lactobacillus; 16S rRNA; Vagina; Gut; Metagenomics; Nigerian women
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: NAUTH/CS/66/V046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No