- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04329338
Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Anambra
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Nnewi, Anambra, Nigeria
- Nnamdi Azikiwe University Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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.
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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
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Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nugent score
Time Frame: 14 days
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Gram stain microscopy for different bacterial morphotypes
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14 days
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Gut and Vaginal microbiota
Time Frame: 14 days
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Relative abundance of bacterial communities before and after Lactobacillus pentosus KCA1
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14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IL-6 Proinflammatory cytokine
Time Frame: 14 days
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Levels of Interleukin-6 with Enzyme-Linked Immunosorbent assay (ELISA)
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14 days
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IL-1beta Proinflammatory cytokine
Time Frame: 14 days
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Level of Interleukin-I beta with Enzyme-Linked Immunosorbent assay (ELISA)
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14 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAUTH/CS/66/V046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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