Vulvovaginal CandidiasisPROVELIANCT06480604
Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis
A study testing Probiotic in people with Vulvovaginal Candidiasis, run by The Archer-Daniels-Midland Company at 6 sites in India.
Trial summary
This study evaluates the effect of a multi-strain probiotic on the risk of recurrence and severity of symptoms in females with recurrent vulvovaginal candidiasis (R-VVC). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 6 sitesIndia
- Study dates
- 15 Oct 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals meeting ALL of the following criteria will be enrolled for the study:
- Premenopausal women aged 18-50 years.
- Women with a culture-confirmed active episode caused by Candida spp. (albicans or non-albicans) reported within 24-48 hours of evidence of clinical symptoms. (No medications should have been initiated before the sample for culture is collected).
- Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture /clinical diagnosis.
- Culture growth of Candida spp. causing VVC.
- Random Capillary Blood Glucose of < 110mg/dl.
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- Willingness to consume the study products for the entire study duration.
- Willing to complete all study procedures and comply with study requirements.
- Willing to abstain from other supplements or medication.
- Ready to give voluntary, written, informed consent to participate in the study.
Who cannot join
- Individuals meeting ANY of the following criteria will be excluded from the study:
- Post-menopausal and peri-menopausal women.
- Pregnant/breast-feeding women.
- Use of oral or vaginal anti-fungal medication in the last 14 days.
- Vaginal culture suggestive of bacterial vaginosis (Nugent's score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
- Participants found positive for Clotrimazole resistance, by vaginal culture \& sensitivity at screening.
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- Known allergy to Clotrimazole.
- Women not willing to use any form of vaginal medication during the study.
- Use of vaginal douching.
- Unwillingness to use an appropriate method of contraception.
- Diagnosed with compromised immune system, type I and/or type II diabetes mellitus, or malignancies.
- Use of corticosteroids therapy in the last 30 days.
- Use of oral/systemic antimicrobial therapy in the last 30 days.
- Known allergy to the study products or azoles.
- Individuals with a history of frequent infections requiring antibiotic treatments.
- Participation in another clinical study(ies) in the last 3 months.
- Women who, in the opinion of the Investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the study.
- Women with uncontrolled hypertension with systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg.
- Heavy alcohol drinkers defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks/week. For women, consuming more than 3 drinks on any day or more than 7 drinks/week.
- Smokers.
- History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the Investigator, would interfere with the participant's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the individual at undue risk.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Use of any supplements (includes probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplements, vitamins with probiotics) in the last 30 days.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
India6 sites, 6 recruiting
- Recruiting
Life Care Hospital
Nashik, Maharashtra
- Recruiting
AMF's Moraya Multispeciality Hospital
Pune, Maharashtra
- Recruiting
ENT & Vertigo Clinic
Pune, Maharashtra
- Recruiting
Vivaan Hospital
Sopāra, Maharashtra
- Recruiting
Anand Multispeciality Hospital
Vadodara, Gujarat
- Recruiting
Matritva Women's Hospital
Vasai, Maharashtra
About this study
Official title: A Pilot Clinical Trial Assessing the Effect of a Multi-strain Probiotic on the Risk of Recurrence and Severity of Symptoms in Females With Recurrent Vulvovaginal Candidiasis
This study evaluates the effect of a multi-strain probiotic on the risk of recurrence and severity of symptoms in females with recurrent vulvovaginal candidiasis (R-VVC).
Read the detailed description
This study aims to investigate the efficacy of live bacteria on the incidence and severity of symptoms of vulvovaginal candidiasis (VVC) recurrence. The trial will be run in India and recruit women with recurrent vulvovaginal candidiasis (R-VVC).
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- Probiotic, Placebo
- Keywords
- Microbiome, Probiotic, Recurrent, Vulvovaginal, Candidiasis, RVVC, Vaginal, Chronic, Infection
- Medical subject headings
- Candidiasis, Vulvovaginal, Recurrence, Candidiasis, Bronchiolitis Obliterans Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Participants in this arm will receive a daily dose of 2x10^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules once daily, for 6 months.
PlaceboDietary supplement
Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants in this arm will receive a daily dose of 2x10^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules once daily, for 6 months. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Participants in this arm will receive an equivalent placebo for the duration of the study (6 months). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo.
Efficacy of a multi-strain probiotic on incidence of culture-confirmed VVC recurrence as compared to placebo, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
Measured: Day 0, Day 180
Secondary outcomes (9)
Occurrence of culture-confirmed VVC recurrence between baseline and day 90 as compared to placebo.
Efficacy of a multi-strain probiotic on incidence of culture-confirmed VVC recurrence as compared to placebo, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
Measured: Day 0, Day 90
Time to first recurrence of VVC episode from baseline between probiotic and placebo groups.
Time to first recurrence of VVC episode from baseline between probiotic and placebo groups, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
Measured: Day 0 to first VVC recurrence
Change in the number of days with VVC episode between probiotic and placebo groups.
Efficacy of a multi-strain probiotic on the number of days with VVC episode as compared to placebo group, where VVC episode is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
Measured: Duration (days) of VVC episodes, Day 0-180.
Change in severity of VVC episodes between probiotic and placebo groups.
Efficacy of a multi-strain probiotic on the severity of VVC episodes as assessed by symptoms (itching/soreness, edema, dysuria, vaginal discharge, dyspareunia, erythema, fissures/excoriations) severity on a 4-point Likert Scale as compared to baseline and placebo.
The number of days of an episode will be captured using the e-dairy. First day of the episode will be considered as the day when the participant experiences onset of at least 2 moderate symptoms or at least one severe symptom on the 4-point Likert scale. The last day of the episode will be considered when there is no presence of VVC related clinical signs and symptoms and thus the composite score on the Likert scale is 0.
Measured: During VVC episodes
Proportion of Candida albicans positive VVC episodes vs other pathogens between probiotic and placebo groups.
Efficacy of a multi-strain probiotic on proportion of Candida albicans positive VVC episodes vs other pathogens.
Measured: During VVC episodes
Number of administrations of vaginal pessaries during acute VVC episodes as compared to baseline and placebo.
Number of vaginal pessaries applied during acute VVC episodes as compared to baseline and placebo. A Clotrimazole 100 mg pessary to be applied once daily at bedtime till no symptoms persist.
Measured: During VVC episodes
Changes in vaginal health as assessed by vaginal pH and compared to baseline and placebo.
Changes in vaginal health as assessed by vaginal pH, compared to baseline and placebo, using pH strips.
Measured: Day 0, Day 90, Day 180
Changes in vaginal microbiology as assessed by vaginal Candida albicans culture and compared to baseline and placebo.
Changes in vaginal microbiology as assessed by vaginal Candida albicans culture and compared to baseline and placebo.
Measured: During episodes
Quality of life as assessed using SF-36 and compared to baseline and placebo.
Changes in quality of life as assessed using SF-36 and compared to baseline and placebo.
Total and individual scoring of the 8 sections of the SF-36 questionnaire will be used to infer the improvement in quality of life improve. A high score defines a more favorable health state (maximum score 100).
Measured: Day 0, Day 90, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start15 Oct 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vedic Lifesciences Pvt. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480604
- Sponsor's protocol ID
- CTB2022TN202
- Acronym
- PROVELIA
- Status last verified
- Nov 2024
- First submitted
- 25 Jun 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial Assessing the Effect of a Multi-strain Probiotic on the Risk of Recurrence and Severity of Symptoms in Females With Recurrent Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT06480604
- Acronym / sponsor ID
- PROVELIA / CTB2022TN202
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- Microbiome, Probiotic, Recurrent, Vulvovaginal, Candidiasis, RVVC, Vaginal, Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Vedic Lifesciences Pvt. Ltd.
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Jun 2024 (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 evaluates the effect of a multi-strain probiotic on the risk of recurrence and severity of symptoms in females with recurrent vulvovaginal candidiasis (R-VVC).
Detailed description
This study aims to investigate the efficacy of live bacteria on the incidence and severity of symptoms of vulvovaginal candidiasis (VVC) recurrence. The trial will be run in India and recruit women with recurrent vulvovaginal candidiasis (R-VVC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticParticipants in this arm will receive a daily dose of 2x10^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules once daily, for 6 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive an equivalent placebo for the duration of the study (6 months). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Premenopausal women aged 18-50 years.
- Women with a culture-confirmed active episode caused by Candida spp. (albicans or non-albicans) reported within 24-48 hours of evidence of clinical symptoms. (No medications should have been initiated before the sample for culture is collected).
- Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture /clinical diagnosis.
- Culture growth of Candida spp. causing VVC.
- Random Capillary Blood Glucose of < 110mg/dl.
Key exclusion criteria (23 listed)
- Post-menopausal and peri-menopausal women.
- Pregnant/breast-feeding women.
- Use of oral or vaginal anti-fungal medication in the last 14 days.
- Vaginal culture suggestive of bacterial vaginosis (Nugent's score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
- Participants found positive for Clotrimazole resistance, by vaginal culture \& sensitivity at screening.
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 |
|---|---|---|
| ProbioticParticipants in this arm will receive a daily dose of 2x10^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules once daily, for 6 months. | Dietary supplement | Probiotic |
| PlaceboParticipants in this arm will receive an equivalent placebo for the duration of the study (6 months). | Dietary supplement | Placebo |
Primary outcome
Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo.
Time frame: Day 0, Day 180
Efficacy of a multi-strain probiotic on incidence of culture-confirmed VVC recurrence as compared to placebo, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
9 secondary outcomes
Occurrence of culture-confirmed VVC recurrence between baseline and day 90 as compared to placebo.
Time frame: Day 0, Day 90
Time to first recurrence of VVC episode from baseline between probiotic and placebo groups.
Time frame: Day 0 to first VVC recurrence
Change in the number of days with VVC episode between probiotic and placebo groups.
Time frame: Duration (days) of VVC episodes, Day 0-180.
Change in severity of VVC episodes between probiotic and placebo groups.
Time frame: During VVC episodes
Proportion of Candida albicans positive VVC episodes vs other pathogens between probiotic and placebo groups.
Time frame: During VVC episodes
Number of administrations of vaginal pessaries during acute VVC episodes as compared to baseline and placebo.
Time frame: During VVC episodes
Changes in vaginal health as assessed by vaginal pH and compared to baseline and placebo.
Time frame: Day 0, Day 90, Day 180
Changes in vaginal microbiology as assessed by vaginal Candida albicans culture and compared to baseline and placebo.
Time frame: During episodes
Quality of life as assessed using SF-36 and compared to baseline and placebo.
Time frame: Day 0, Day 90, Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Vulvovaginal Candidiasis, run by The Archer-Daniels-Midland Company at 6 sites in India.
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 10 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ADM Medical Team (+441460243230, medical@protexin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo. (time frame: Day 0, Day 180). 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 7 Nov 2024.