Bacterial VaginosesNCT04329338
Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis
A study testing Lactobacillus pentosus KCA1 in people with Bacterial Vaginoses, run by Nnamdi Azikiwe University at 1 site in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginoses
- What is being tested?
- Lactobacillus pentosus KCA1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNigeria
- Study dates
- 8 Nov 2017to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not on antibiotic therapy within the last one month
- Not menstruating at the time of inclusion.
Who cannot join
- Pregnant, use of antibiotic medication, declined informed consent, menstruating and those that used douches, sprays, spermicides in the last 48 hours
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bacterial Vaginoses
- Being tested
- Lactobacillus pentosus KCA1
- Keywords
- Lactobacillus, Microbiota, Nigerian women, Gut, Vagina, 16S rRNA, Sequencing, Metagenomics
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus pentosus KCA1Other
Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Lactobacillus pentosus KCA1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nugent score
Gram stain microscopy for different bacterial morphotypes
Measured: 14 days
Gut and Vaginal microbiota
Relative abundance of bacterial communities before and after Lactobacillus pentosus KCA1
Measured: 14 days
Secondary outcomes (2)
IL-6 Proinflammatory cytokine
Levels of Interleukin-6 with Enzyme-Linked Immunosorbent assay (ELISA)
Measured: 14 days
IL-1beta Proinflammatory cytokine
Level of Interleukin-I beta with Enzyme-Linked Immunosorbent assay (ELISA)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start8 Nov 2017
- Primary completion20 Sep 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- In this case each participant served as control as we collected sample before and after intervention
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nnamdi Azikiwe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kingsley C Anukam, Nnamdi Azikiwe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329338
- Sponsor's protocol ID
- NAUTH/CS/66/V046
- Status last verified
- Mar 2020
- First submitted
- 27 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23527145
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT04329338
- Acronym / sponsor ID
- NAUTH/CS/66/V046
- Conditions
- Bacterial Vaginoses
- Keywords
- Lactobacillus, Microbiota, Nigerian women, Gut, Vagina, 16S rRNA, Sequencing, Metagenomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Nnamdi Azikiwe UniversityUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this case each participant served as control as we collected sample before and after intervention
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Lactobacillus pentosus KCA1Seven 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 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Not on antibiotic therapy within the last one month
- Not menstruating at the time of inclusion.
Key exclusion criteria (2 listed)
- Pregnant, use of antibiotic medication, declined informed consent, menstruating and those that used douches, sprays, spermicides in the last 48 hours
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus pentosus KCA1Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days | Other | Gut and Vaginal sample after Lactobacillus |
Primary outcome
Nugent score
Time frame: 14 days
Gram stain microscopy for different bacterial morphotypes
Gut and Vaginal microbiota
Time frame: 14 days
Relative abundance of bacterial communities before and after Lactobacillus pentosus KCA1
2 secondary outcomes
IL-6 Proinflammatory cytokine
Time frame: 14 days
IL-1beta Proinflammatory cytokine
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Background: PubMed 23527145Anukam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus pentosus KCA1 in people with Bacterial Vaginoses, run by Nnamdi Azikiwe University at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nugent score (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04329338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.