Vaginal CandidiasisNCT00915629
Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®
A study testing Lactibiane candisis 5M in people with Vaginal Candidiasis, run by PiLeJe at 1 site in France.
Trial summary
Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with considerable morbidity and health-care cost. 75% of women will suffer of Candida infection for at least one time in their life. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vaginal Candidiasis
- What is being tested?
- Lactibiane candisis 5M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Jul 2010
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women
- 18-65 years
- suffering from 4 or more episodes of VVC during the 1 year prior to the survey
- all participants must be symptomatic with a microbiological proof of infection with candida albicans
Who cannot join
- Pregnancy, lactation being
- HIV infection, chemotherapy or illness serious enough to induce an immune deficiency. A diabetic patient will not be systematically excluded;
- Vulvo-vaginitis and / or cervicitis specific, defined in a bacteriological examination by the presence of herpes virus, gonorrhea or chlamydia;
- Bacterial Vaginosis or Trichomonas;
- Use of vaginal probiotics in the months before inclusion;
- Cure of probiotics in the months preceding the inclusion;
- Contraindication to Gynopévaryl LP
Trial locations and contacts
1 site in 1 country.
About this study
Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with considerable morbidity and health-care cost. 75% of women will suffer of Candida infection for at least one time in their life. 20% of women who suffer from VVC will have ≥ 4 episodes of VVC during the one year prior to the survey. 80% of these VVC are caused by Candida albicans. Current treatments, based on imidazoles, face many failures or recurrences. The type of probiotic Lactobacillus may participate in the prevention of recurrent vulvo-vaginitis in reducing the proliferation of intestinal Candida albicans, its adherence to the vaginal walls, the potentiation of its propagation. The primary objective of this study was to investigate if our supplementary treatment could improve the initial cure rate after vaginal econazole therapy.
- Conditions
- Vaginal Candidiasis
- Being tested
- Lactibiane candisis 5M
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactibiane candisis 5MDietary supplement
2 gelules per day for 2 months then 1 gelule per day for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Dietary supplement Receives: Dietary Supplement: Lactibiane candisis 5M |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study was to investigate if Lactibiane candisis 5M supplementation could lengthen the time to relapse after initial local cure
Measured: 9 months
Secondary outcomes (1)
The secondary objective of this study is to compare the number of recurrence in the lactibiane candisis 5M group versus placebo.
Measured: 2, 3, 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2010
- Study completionJul 2010
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 Vaginal CandidiasisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- AZOULAY Catherine, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915629
- Sponsor's protocol ID
- 2008-A01513-52
- Status last verified
- Apr 2021
- First submitted
- 4 Jun 2009
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Cooke G, Watson C, Deckx L, Pirotta M, Smith J, van Driel ML. Treatment for recurrent vulvovaginal candidiasis (thrush). Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD009151. doi: 10.1002/14651858.CD009151.pub2.
PubMed 35005777
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®
- ClinicalTrials.gov ID
- NCT00915629
- Acronym / sponsor ID
- 2008-A01513-52
- Conditions
- Vaginal Candidiasis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- Jun 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 8 Jun 2009 (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.
Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with considerable morbidity and health-care cost. 75% of women will suffer of Candida infection for at least one time in their life. 20% of women who suffer from VVC will have ≥ 4 episodes of VVC during the one year prior to the survey. 80% of these VVC are caused by Candida albicans. Current treatments, based on imidazoles, face many failures or recurrences. The type of probiotic Lactobacillus may participate in the prevention of recurrent vulvo-vaginitis in reducing the proliferation of intestinal Candida albicans, its adherence to the vaginal walls, the potentiation of its propagation. The primary objective of this study was to investigate if our supplementary treatment could improve the initial cure rate after vaginal econazole therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Lactibiane candisis 5MDietary supplement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women
- 18-65 years
- suffering from 4 or more episodes of VVC during the 1 year prior to the survey
- all participants must be symptomatic with a microbiological proof of infection with candida albicans
Key exclusion criteria (7 listed)
- Pregnancy, lactation being
- HIV infection, chemotherapy or illness serious enough to induce an immune deficiency. A diabetic patient will not be systematically excluded;
- Vulvo-vaginitis and / or cervicitis specific, defined in a bacteriological examination by the presence of herpes virus, gonorrhea or chlamydia;
- Bacterial Vaginosis or Trichomonas;
- Use of vaginal probiotics in the months before inclusion;
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 |
|---|---|---|
| Lactibiane candisis 5M2 gelules per day for 2 months then 1 gelule per day for 4 months | Dietary supplement | Probiotic |
Primary outcome
The primary objective of this study was to investigate if Lactibiane candisis 5M supplementation could lengthen the time to relapse after initial local cure
Time frame: 9 months
1 secondary outcome
The secondary objective of this study is to compare the number of recurrence in the lactibiane candisis 5M group versus placebo.
Time frame: 2, 3, 6 and 9 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 35005777Cooke G, Watson C, Deckx L, Pirotta M, Smith J, van Driel ML. Treatment for recurrent vulvovaginal candidiasis (thrush). Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD009151. doi: 10.1002/14651858.CD009151.pub2.
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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.
AZOULAY Catherine, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactibiane candisis 5M in people with Vaginal Candidiasis, run by PiLeJe at 1 site in France.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Apr 2021. 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 France. 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 was stopped early. Results are not available in the source record.
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?
The primary objective of this study was to investigate if Lactibiane candisis 5M supplementation could lengthen the time to relapse after initial local cure (time frame: 9 months). 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 NCT00915629, 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 20 Apr 2021.