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

Bacterial Vaginoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329338
• Other study ID #: NAUTH/CS/66/V046
• Status: Completed
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: December 10, 2019

Study information

• Verified date: March 2020
• Source: Nnamdi Azikiwe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 10, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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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Related Conditions & MeSH terms

• Bacterial Vaginoses
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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

Locations

Country	Name	City	State
Nigeria	Nnamdi Azikiwe University Teaching Hospital	Nnewi	Anambra

Sponsors (1)

Lead Sponsor	Collaborator
Nnamdi Azikiwe University

Country where clinical trial is conducted

Nigeria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nugent score	Gram stain microscopy for different bacterial morphotypes	14 days
Primary	Gut and Vaginal microbiota	Relative abundance of bacterial communities before and after Lactobacillus pentosus KCA1	14 days
Secondary	IL-6 Proinflammatory cytokine	Levels of Interleukin-6 with Enzyme-Linked Immunosorbent assay (ELISA)	14 days
Secondary	IL-1beta Proinflammatory cytokine	Level of Interleukin-I beta with Enzyme-Linked Immunosorbent assay (ELISA)	14 days