Back to resultsEffects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis
Primary Purpose
Bacterial Vaginoses
Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Lactobacillus pentosus KCA1
Sponsored by
About this trial
This is an interventional supportive care trial for Bacterial Vaginoses focused on measuring Lactobacillus, Microbiota, Nigerian women, Gut, Vagina, 16S rRNA, Sequencing, Metagenomics
Eligibility Criteria
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
-
Sites / Locations
- Nnamdi Azikiwe University Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Gut and vaginal sample collection
Gut and Vaginal sample after Lactobacillus
Arm Description
Gut and vaginal samples were collected for Nugent score, and 16S rRNA metagenomics communities.
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
Outcomes
Primary Outcome Measures
Nugent score
Gram stain microscopy for different bacterial morphotypes
Gut and Vaginal microbiota
Relative abundance of bacterial communities before and after Lactobacillus pentosus KCA1
Secondary Outcome Measures
IL-6 Proinflammatory cytokine
Levels of Interleukin-6 with Enzyme-Linked Immunosorbent assay (ELISA)
IL-1beta Proinflammatory cytokine
Level of Interleukin-I beta with Enzyme-Linked Immunosorbent assay (ELISA)
Full Information
NCT ID
NCT04329338
First Posted
March 27, 2020
Last Updated
March 31, 2020
Sponsor
Nnamdi Azikiwe University
1. Study Identification
Unique Protocol Identification Number
NCT04329338
Brief Title
Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis
Official Title
Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nnamdi Azikiwe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginoses
Keywords
Lactobacillus, Microbiota, Nigerian women, Gut, Vagina, 16S rRNA, Sequencing, Metagenomics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In this case each participant served as control as we collected sample before and after intervention
Masking
None (Open Label)
Masking Description
This is an open label study
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gut and vaginal sample collection
Arm Type
No Intervention
Arm Description
Gut and vaginal samples were collected for Nugent score, and 16S rRNA metagenomics communities.
Arm Title
Gut and Vaginal sample after Lactobacillus
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Lactobacillus pentosus KCA1
Intervention Description
Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days
Primary Outcome Measure Information:
Title
Nugent score
Description
Gram stain microscopy for different bacterial morphotypes
Time Frame
14 days
Title
Gut and Vaginal microbiota
Description
Relative abundance of bacterial communities before and after Lactobacillus pentosus KCA1
Time Frame
14 days
Secondary Outcome Measure Information:
Title
IL-6 Proinflammatory cytokine
Description
Levels of Interleukin-6 with Enzyme-Linked Immunosorbent assay (ELISA)
Time Frame
14 days
Title
IL-1beta Proinflammatory cytokine
Description
Level of Interleukin-I beta with Enzyme-Linked Immunosorbent assay (ELISA)
Time Frame
14 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
-
Facility Information:
Facility Name
Nnamdi Azikiwe University Teaching Hospital
City
Nnewi
State/Province
Anambra
Country
Nigeria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23527145
Citation
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.
Results Reference
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Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis
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