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

NCT04329338 | Completed DMC

• 1 other identifier: NAUTH/CS/66/V046
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Vaginoses

Keywords

Lactobacillus; Microbiota; Nigerian women; Gut; Vagina; 16S rRNA; Sequencing; Metagenomics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• IL-6 Proinflammatory cytokine

  14 days

• IL-1beta Proinflammatory cytokine

  14 days

Study Arms (2)

Gut and vaginal sample collection

NO INTERVENTION

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

Gut and Vaginal sample after Lactobacillus

EXPERIMENTAL

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

Interventions

Lactobacillus pentosus KCA1 OTHER

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

Gut and Vaginal sample after Lactobacillus

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Not on antibiotic therapy within the last one month

You may not qualify if:

• Pregnant, use of antibiotic medication, declined informed consent, menstruating and those that used douches, sprays, spermicides in the last 48 hours

Sponsors & Collaborators

• Nnamdi Azikiwe University: lead

Study Sites (1)

Nnamdi Azikiwe University Teaching Hospital

Nnewi, Anambra, Nigeria

Location

Related 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.

  PMID: 23527145 BACKGROUND

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader/Research Scientist

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

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 1, 2020
• Study Start: November 8, 2017
• Primary Completion: September 20, 2019
• Study Completion: December 10, 2019
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)