Vulvovaginal CandidiasisEarly Phase 1RVMMNCT02150655
Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women
A Early Phase 1 study testing Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules in people with Vulvovaginal Candidiasis and Bacterial Vaginosis, run by Western University, Canada at 1 site in Rwanda.
Trial summary
The overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Candidiasis, Bacterial Vaginosis
- What is being tested?
- Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteRwanda
- Study dates
- Sep 2012to Dec 2013
- Phase
- Early Phase 1
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women between the ages of 18 and 55.
Who cannot join
- *Current infection of gonorrhoea, *Chlamydia, genital warts, *active genital herpes lesions, *active syphilis; *urinary tract infection including pyelonephritis (an ascending urinary tract infection); *receiving drug therapy that may affect the vaginal flora; *had unprotected sexual intercourse (vaginal or oral) within the past 48 hours; *have used a vaginal douche, genital deodorant, or genital wipe products in the past 48 hours; *have taken any 'acidophilus' 'bifidobacteria' or probiotic health food supplements in the past 48 hours; *are menstruating at time of clinical visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Investigating Bacteria (Microbiota), Their By-products (Metabolome) and Environmental Toxins in Relation to Reproductive Health in Rwandan Women.
The overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a healthy state and lower environmental toxins will be completed.
- Conditions
- Vulvovaginal Candidiasis, Bacterial Vaginosis
- Being tested
- Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules, Placebo
- Medical subject headings
- Candidiasis, Vulvovaginal, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus GR-1 and Lactobacillus RC-14 oral capsulesBiological
PlaceboBiological
Also called Sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 oral capsules Receives: Biological: Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules |
| Placebo | Placebo comparator | Sugar pill Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
maintenance of healthy vaginal microbiota
The change in relative abundance of healthy lactobacilli and species associated with bacterial vaginosis after one month probiotic intervention will be assessed using 16S rRNA gene sequencing.
Measured: 1 month
Secondary outcomes (1)
Reduction of environmental toxins in blood by lactobacilli
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionDec 2013
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 Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gregor Reid, Western University, Canada
- Investigators
- Gregor Dr Reid, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150655
- Sponsor's protocol ID
- 102886
- Acronym
- RVMM
- Status last verified
- May 2014
- First submitted
- 4 Jul 2013
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McMillan A, Rulisa S, Gloor GB, Macklaim JM, Sumarah M, Reid G. Pilot assessment of probiotics for pregnant women in Rwanda. PLoS One. 2018 Jun 18;13(6):e0195081. doi: 10.1371/journal.pone.0195081. eCollection 2018.
PubMed 29912913
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Investigating Bacteria (Microbiota), Their By-products (Metabolome) and Environmental Toxins in Relation to Reproductive Health in Rwandan Women.
- ClinicalTrials.gov ID
- NCT02150655
- Acronym / sponsor ID
- RVMM / 102886
- Conditions
- Vulvovaginal Candidiasis, Bacterial Vaginosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 May 2014 (estimated)
- 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.
The overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a healthy state and lower environmental toxins will be completed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Biological: Lactobacillus GR-1 and Lactobacillus RC-14 oral capsulesLactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 oral capsules |
| Placebo | Placebo comparator | Biological: PlaceboSugar pill |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women between the ages of 18 and 55.
Key exclusion criteria (1 listed)
- *Current infection of gonorrhoea, *Chlamydia, genital warts, *active genital herpes lesions, *active syphilis; *urinary tract infection including pyelonephritis (an ascending urinary tract infection); *receiving drug therapy that may affect the vaginal flora; *had unprotected sexual intercourse (vaginal or oral) within the past 48 hours; *have used a vaginal douche, genital deodorant, or genital wipe products in the past 48 hours; *have taken any 'acidophilus' 'bifidobacteria' or probiotic health food supplements in the past 48 hours; *are menstruating at time of clinical visit.
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 GR-1 and Lactobacillus RC-14 oral capsules | Biological | Probiotic |
| PlaceboAlso: Sugar pill | Biological | Placebo |
Primary outcome
maintenance of healthy vaginal microbiota
Time frame: 1 month
The change in relative abundance of healthy lactobacilli and species associated with bacterial vaginosis after one month probiotic intervention will be assessed using 16S rRNA gene sequencing.
1 secondary outcome
Reduction of environmental toxins in blood by lactobacilli
Time frame: 1 month
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 30 May 2014.
- Derived from this study: PubMed 29912913McMillan A, Rulisa S, Gloor GB, Macklaim JM, Sumarah M, Reid G. Pilot assessment of probiotics for pregnant women in Rwanda. PLoS One. 2018 Jun 18;13(6):e0195081. doi: 10.1371/journal.pone.0195081. eCollection 2018.
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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.
Gregor Dr Reid, PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules in people with Vulvovaginal Candidiasis and Bacterial Vaginosis, run by Western University, Canada at 1 site in Rwanda.
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 1 inclusion and 1 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 30 May 2014. 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 Rwanda. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
maintenance of healthy vaginal microbiota (time frame: 1 month). 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 NCT02150655, 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 30 May 2014.