Candidiasis, VulvovaginalNCT03975569
Study of the Vaginal Microbiota and the Potential of a Vaginal Probiotic Cream in Vaginal Candidosis
A study testing Probiotic vaginal gel in people with Candidiasis, Vulvovaginal, run by University Hospital, Antwerp.
Trial summary
This study evaluated the effect of a vaginal gel containing three live probiotic bacteria on vaginal Candida albicans infection in flemish patients (n=20). The therapeutic effects of the gel will be clinically evaluated (vaginal pH, microscopic and clinical scores). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Candidiasis, Vulvovaginal
- What is being tested?
- Probiotic vaginal gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2016to 31 Mar 2017
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent
- willing to adhere to protocol
- premenopausal
- positive Candida microscopy and/or culture
- at least two of the following vaginal symptoms: burning, itching, redness, fissure, discharge, vulvar edema, postcoital itching, lesions with partner
Who cannot join
- vaginal use of any products 1 week or less before randomization
- use of oral or local antimycotic treatment 1 week or less before randomization
- unprotected sexual contact 24 hours preceding randomization
- vaginal douching 24 hours preceding randomization
- patient does not agree to participate in the study
About this study
Official title: Studie Van de Vaginale Microbiota en Het Potentieel Van Een Vaginale Zalf Met Probiotica Bij Vaginale Candidose
This study evaluated the effect of a vaginal gel containing three live probiotic bacteria on vaginal Candida albicans infection in flemish patients (n=20). The therapeutic effects of the gel will be clinically evaluated (vaginal pH, microscopic and clinical scores). The effect on the vaginal microbiome will be evaluated through 16S ribosomal RNA amplicon sequencing via MiSeq Illumina and polymerase chain reaction (PCR) for Candida albicans.
- Conditions
- Candidiasis, Vulvovaginal
- Being tested
- Probiotic vaginal gel
- Keywords
- vaginal, yeast infection, candida, candidosis
- Medical subject headings
- Candidiasis, Vulvovaginal, Torulopsis, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic vaginal gelOther
Total daily administration of 2.5 ml of probiotic gel, containing three lactobacilli (Lactobacillus rhamnosus GG, Lactobacillus pentosus KCA1 and Lactobacillus plantarum WCFS1). Final dosage per gram of gel: 10^9-10^10 colony forming units of lactobacilli.
| Study group | Role | What they receive |
|---|---|---|
| vulvovaginitis patients- lactobacillus gel | Experimental | Daily use of vaginal gel containing lactobacilli by patients. Probiotic vaginal gel. Receives: Other: Probiotic vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal persistence of Candida species
The presence of Candida species in the collected samples will be analyzed by microscopy, culture (clinical lab) and after DNA extraction through quantitative PCR as molecular method. This will allow to estimate relative and absolute concentrations of the suspected infectious agent, and allow to evaluate if the infection cleared or not.
Measured: through study completion, estimated 1 year
Secondary outcomes (2)
Clinical scores of patients
By the responsible gynecologist, symptom severity (burning, itching, redness, swelling and fissures) was estimated and scored as absent, mild, moderate or severe. This will provide information about the ability of the gel to ameliorate the symptoms of vulvovaginal candidosis.
Measured: through study completion, estimated 1 year
Microbiome analysis
After Illumina MiSeq sequencing, bio-informatics tools will be used to cluster bacteria and yeasts into operation taxonomic units/ amplicon sequence variants (ASVs). Based on these ASVs, the bacterial and fungal community will be compared over the sampled periods and allow comparison of the composition over the study period. The investigators will specifically screen for ASVs that can be expected to be derived from supplied probiotic strains or that are responsible for the infection (expected Candida ASVs). Additionally, the investigators will pay attention to the dominant members of the vaginal bacterial community (expected in most women to be dominated by one of four Lactobacillus species).
Measured: through study completion, estimated 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start4 Apr 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, VulvovaginalStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité, UZA, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975569
- Sponsor's protocol ID
- 16/7/66
- Other IDs
- B300201628296
- Status last verified
- Jun 2019
- First submitted
- 12 Feb 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studie Van de Vaginale Microbiota en Het Potentieel Van Een Vaginale Zalf Met Probiotica Bij Vaginale Candidose
- ClinicalTrials.gov ID
- NCT03975569
- Acronym / sponsor ID
- 16/7/66
- Conditions
- Candidiasis, Vulvovaginal
- Keywords
- vaginal, yeast infection, candida, candidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 5 Jun 2019 (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.
This study evaluated the effect of a vaginal gel containing three live probiotic bacteria on vaginal Candida albicans infection in flemish patients (n=20). The therapeutic effects of the gel will be clinically evaluated (vaginal pH, microscopic and clinical scores). The effect on the vaginal microbiome will be evaluated through 16S ribosomal RNA amplicon sequencing via MiSeq Illumina and polymerase chain reaction (PCR) for Candida albicans.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vulvovaginitis patients- lactobacillus gel | Experimental | Other: Probiotic vaginal gelDaily use of vaginal gel containing lactobacilli by patients. Probiotic vaginal gel. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent
- willing to adhere to protocol
- premenopausal
- positive Candida microscopy and/or culture
- at least two of the following vaginal symptoms: burning, itching, redness, fissure, discharge, vulvar edema, postcoital itching, lesions with partner
Key exclusion criteria (5 listed)
- vaginal use of any products 1 week or less before randomization
- use of oral or local antimycotic treatment 1 week or less before randomization
- unprotected sexual contact 24 hours preceding randomization
- vaginal douching 24 hours preceding randomization
- patient does not agree to participate in the study
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 |
|---|---|---|
| Probiotic vaginal gelTotal daily administration of 2.5 ml of probiotic gel, containing three lactobacilli (Lactobacillus rhamnosus GG, Lactobacillus pentosus KCA1 and Lactobacillus plantarum WCFS1). Final dosage per gram of gel: 10^9-10^10 colony forming units of lactobacilli. | Other | vulvovaginitis patients- lactobacillus gel |
Primary outcome
Vaginal persistence of Candida species
Time frame: through study completion, estimated 1 year
The presence of Candida species in the collected samples will be analyzed by microscopy, culture (clinical lab) and after DNA extraction through quantitative PCR as molecular method. This will allow to estimate relative and absolute concentrations of the suspected infectious agent, and allow to evaluate if the infection cleared or not.
2 secondary outcomes
Clinical scores of patients
Time frame: through study completion, estimated 1 year
Microbiome analysis
Time frame: through study completion, estimated 1 year
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 5 Jun 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic vaginal gel in people with Candidiasis, Vulvovaginal, run by University Hospital, Antwerp.
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 5 inclusion and 5 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 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Vaginal persistence of Candida species (time frame: through study completion, estimated 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2019.