Vaginal CandidiasisPhase 2/3NCT06474247
Postbiotic as Adjunct Treatment for Vaginal Candidiasis
A Phase 2/3 study testing Postbiotic in people with Vaginal Candidiasis, run by Min-Tze LIONG at 2 sites in 2 countries.
Trial summary
This project aims to study the efficacy of oral administration of postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 81 years, women only
- Conditions the study is for
- Vaginal Candidiasis
- What is being tested?
- Postbiotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Jun 2024to 30 Apr 2026
- Phase
- Phase 2/3
- 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 81 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are sexually active
- Confirmed with candidiasis as confirmed via clinical observations which include creamy whitish vaginal discharge and vulva-vaginal itchiness
- Willing to commit throughout the experiment
Who cannot join
- Long term medication (6 months or more) for any illnesses
- Pregnant
- Menopaused
- Uterus and/or cervix removed
- Cervical intraepithelial neoplasia
- Vaginal suppository treatments within 4-weeks prior to entering the study
Show all 11Show fewer
- Oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study
- Have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study
- Have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study
- Have used spermicide agent within 4-weeks prior to entering the study
- Have pelvic or any gynecologic surgery 6-months prior to entering the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Use of Postbiotic as Adjunct Treatment for Vaginal Candidiasis in Women
This project aims to study the efficacy of oral administration of postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks compared to placebo.
Read the detailed description
Probiotics are live microorganisms that grant health effects to the host if consumed in sufficient amounts. Probiotic bacteria, which beneficially affect the host by improving the intestinal microbial balance, may affect the immune response, thus boosting the body system to combat against diseases. Meanwhile, postbiotic is an inactivated probiotic, probiotic-produced metabolites or their combination, which is capable of conferring beneficial effects to the host. Postbiotic has added advantages as compared to probiotic where inactivated cellular components remain potent though excluding any allergic factors, while the beneficial metabolites are applied directly to host upon administration and useful for applications such as skin topical use and intravaginal routes.
Vaginitis has been considered as one of the most common gynaecological conditions affecting women worldwide. Bacterial vaginosis and yeast vaginitis are two of three urogenital infections that affect as estimated one billion women in the world annually. The prevalence of vaginitis was reported to be varied from 5% to 50% among different study populations across major continents such as the United States of America, Europe and South Asia.
Vaginal candidiasis is one of the most common gynecological problems seen in primary care with Candida albicans account for 90% of the infection. The over-growth of this fungus in the vagina leads to a burning sensation in the vagina vulva, the production of heavy white/yellow curd-like discharge and/or an itchy vulva, puritus, dyspareunia, dysuria, irritation, soreness of the vulva and other discomforting symptoms that will ensure frequent hospital visits. The symptoms of vaginal candidiasis include vaginal itching or soreness, pain during sexual intercourse, pain or discomfort when urinating and abnormal vaginal discharge. Although most vaginal candidiasis is mild, some women can develop severe infections involving redness, swelling, and cracks in the wall of the vagina. It is also a most common form of fungal infection in pregnant mothers which may cause systemic infections in neonate particularly with low birth weight and prematurity after delivery.
Probiotics are preferred compared to antibacterial and antifungal drugs due to infection recurrence and drug resistance. It is a main concern that overuse of antibiotics could result in the development of antibiotic-resistant bacteria and fungus. Therefore, it is vital to find other alternatives to treat vaginal infections.
The maintenance of healthy vaginal microbiota is important for optimal vaginal microenvironment. Jang and team reported that intravaginal administration of probiotic mixture increased the regulation of vaginal IL-10 and Foxp3. As this may be due to the probiotic regulatory effects on immune responses in the vagina. A clinical study from Norway and Sweden found that the treatment with antibiotics or anti-fungal medication in combination with probiotics provided long-term cure against recurrence of vaginal candidiasis as compared to the control.
During the past several decades, the many published surveys of vaginal flora specimens obtained from asymptomatic women have clearly shown that C. albicans may be present without the typical symptoms of yeast vaginitis. In a study by Glover and Larsen, the results of successive cultures of vaginal flora specimens indicated that Candida species may be present in stable association with the genital epithelium. Moreover, the majority of women who have vaginal yeast also carry the organism in the gut.
In women, vaginal candidiasis has been related to emotional stress and suppression of immune system which step up the risk of Candida species overgrowth and become pathogenic. In addition, another study involving 512 women with candidiasiss reported a substantial negative impact on quality of life, with 42% feeling out of control of their lives and 60% feeling out of control of their bodies. Forty-one percent indicated a severe impact on their sexual lives. Meanwhile, 30% of women with recurrent episodes of candidiasis have reported considerable morbidity and suffering. The summary scores of the SF-36 in topic of subjective health status and health-related quality of life among women with Recurrent Vulvovaginal Candidosis (RVVC) in Europe and the USA also suggested that mental health was strongly affected by RVVC.
Current reports primarily emphasize on clinical effects of probiotics against candidiasis in women, with only few reports specifically on efficacy against recurrences. Very recent data are beginning to report on microbiota profiles of vaginal and feces of women with candidiasis, albeit rare. There have been no reports on these aspects from postbiotics. Information on proteins concentration, gene expression of vaginal microenvironment as affected by postbiotics against candidiasis are thus crucial. Thus, it is hoped that via this research, new scientific data is generated for future knowledge on these aspects, for use of postbiotics as an adjunct treatment against VC and RVVC.
- Conditions
- Vaginal Candidiasis
- Being tested
- Postbiotic, Placebo
- Keywords
- probiotic, postbiotic, vaginal candidiasis
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostbioticDevice
Postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks
PlaceboDevice
Placebo at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks
| Study group | Role | What they receive |
|---|---|---|
| Postbiotic | Experimental | Postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks Receives: Device: Postbiotic |
| Placebo | Placebo comparator | Placebo at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vulvovaginal symptoms of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via Vulvovaginal Symptoms Questionnaire (VSQ)
Differences in vulvovaginal symptoms of women with vaginal candidiasis upon administration of postbiotic compared to placebo
Measured: 4-weeks
Secondary outcomes (2)
Vaginal microbiota profiles of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via metagenomics sequencing
Differences in vaginal microbiota profiles of women with vaginal candidiasis upon administration of postbiotic compared to placebo
Measured: 4-weeks
Vaginal and vulvar conditions of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via the VAS-VuAS questionnaire
Differences in vaginal and vulvar conditions scores of women with vaginal candidiasis upon administration of postbiotic compared to placebo
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start2 Jun 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Min-Tze LIONG
- Sponsor type
- University, hospital or other
- Collaborators
- AIMST University, Sumita Hospital
- Responsible party
- Sponsor-investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Sumita Bhatia, MD, Principal investigator, Sumita Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474247
- Sponsor's protocol ID
- NIEC/INDT/APP/10/20/24-01
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2024
- Last updated
- 7 Jul 2026
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Postbiotic as Adjunct Treatment for Vaginal Candidiasis in Women
- ClinicalTrials.gov ID
- NCT06474247
- Acronym / sponsor ID
- NIEC/INDT/APP/10/20/24-01
- Conditions
- Vaginal Candidiasis
- Keywords
- probiotic, postbiotic, vaginal candidiasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Min-Tze LIONGUniversity, hospital or other
- Collaborators
- AIMST University, Sumita Hospital
- Study start
- 2 Jun 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 25 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 project aims to study the efficacy of oral administration of postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks compared to placebo.
Detailed description
Probiotics are live microorganisms that grant health effects to the host if consumed in sufficient amounts. Probiotic bacteria, which beneficially affect the host by improving the intestinal microbial balance, may affect the immune response, thus boosting the body system to combat against diseases. Meanwhile, postbiotic is an inactivated probiotic, probiotic-produced metabolites or their combination, which is capable of conferring beneficial effects to the host. Postbiotic has added advantages as compared to probiotic where inactivated cellular components remain potent though excluding any allergic factors, while the beneficial metabolites are applied directly to host upon administration and useful for applications such as skin topical use and intravaginal routes.
Vaginitis has been considered as one of the most common gynaecological conditions affecting women worldwide. Bacterial vaginosis and yeast vaginitis are two of three urogenital infections that affect as estimated one billion women in the world annually. The prevalence of vaginitis was reported to be varied from 5% to 50% among different study populations across major continents such as the United States of America, Europe and South Asia.
Vaginal candidiasis is one of the most common gynecological problems seen in primary care with Candida albicans account for 90% of the infection. The over-growth of this fungus in the vagina leads to a burning sensation in the vagina vulva, the production of heavy white/yellow curd-like discharge and/or an itchy vulva, puritus, dyspareunia, dysuria, irritation, soreness of the vulva and other discomforting symptoms that will ensure frequent hospital visits. The symptoms of vaginal candidiasis include vaginal itching or soreness, pain during sexual intercourse, pain or discomfort when urinating and abnormal vaginal discharge. Although most vaginal candidiasis is mild, some women can develop severe infections involving redness, swelling, and cracks in the wall of the vagina. It is also a most common form of fungal infection in pregnant mothers which may cause systemic infections in neonate particularly with low birth weight and prematurity after delivery.
Probiotics are preferred compared to antibacterial and antifungal drugs due to infection recurrence and drug resistance. It is a main concern that overuse of antibiotics could result in the development of antibiotic-resistant bacteria and fungus. Therefore, it is vital to find other alternatives to treat vaginal infections.
The maintenance of healthy vaginal microbiota is important for optimal vaginal microenvironment. Jang and team reported that intravaginal administration of probiotic mixture increased the regulation of vaginal IL-10 and Foxp3. As this may be due to the probiotic regulatory effects on immune responses in the vagina. A clinical study from Norway and Sweden found that the treatment with antibiotics or anti-fungal medication in combination with probiotics provided long-term cure against recurrence of vaginal candidiasis as compared to the control.
During the past several decades, the many published surveys of vaginal flora specimens obtained from asymptomatic women have clearly shown that C. albicans may be present without the typical symptoms of yeast vaginitis. In a study by Glover and Larsen, the results of successive cultures of vaginal flora specimens indicated that Candida species may be present in stable association with the genital epithelium. Moreover, the majority of women who have vaginal yeast also carry the organism in the gut.
In women, vaginal candidiasis has been related to emotional stress and suppression of immune system which step up the risk of Candida species overgrowth and become pathogenic. In addition, another study involving 512 women with candidiasiss reported a substantial negative impact on quality of life, with 42% feeling out of control of their lives and 60% feeling out of control of their bodies. Forty-one percent indicated a severe impact on their sexual lives. Meanwhile, 30% of women with recurrent episodes of candidiasis have reported considerable morbidity and suffering. The summary scores of the SF-36 in topic of subjective health status and health-related quality of life among women with Recurrent Vulvovaginal Candidosis (RVVC) in Europe and the USA also suggested that mental health was strongly affected by RVVC.
Current reports primarily emphasize on clinical effects of probiotics against candidiasis in women, with only few reports specifically on efficacy against recurrences. Very recent data are beginning to report on microbiota profiles of vaginal and feces of women with candidiasis, albeit rare. There have been no reports on these aspects from postbiotics. Information on proteins concentration, gene expression of vaginal microenvironment as affected by postbiotics against candidiasis are thus crucial. Thus, it is hoped that via this research, new scientific data is generated for future knowledge on these aspects, for use of postbiotics as an adjunct treatment against VC and RVVC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postbiotic | Experimental | Device: PostbioticPostbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks |
| Placebo | Placebo comparator | Device: PlaceboPlacebo at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who are sexually active
- Confirmed with candidiasis as confirmed via clinical observations which include creamy whitish vaginal discharge and vulva-vaginal itchiness
- Willing to commit throughout the experiment
Key exclusion criteria (11 listed)
- Long term medication (6 months or more) for any illnesses
- Pregnant
- Menopaused
- Uterus and/or cervix removed
- Cervical intraepithelial neoplasia
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 |
|---|---|---|
| PostbioticPostbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks | Device | Postbiotic |
| PlaceboPlacebo at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks | Device | Placebo |
Primary outcome
Vulvovaginal symptoms of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via Vulvovaginal Symptoms Questionnaire (VSQ)
Time frame: 4-weeks
Differences in vulvovaginal symptoms of women with vaginal candidiasis upon administration of postbiotic compared to placebo
2 secondary outcomes
Vaginal microbiota profiles of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via metagenomics sequencing
Time frame: 4-weeks
Vaginal and vulvar conditions of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via the VAS-VuAS questionnaire
Time frame: 4-weeks
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
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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.
Sumita Bhatia, MD principal investigator
Sumita Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Postbiotic in people with Vaginal Candidiasis, run by Min-Tze LIONG at 2 sites in 2 countries.
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 3 inclusion and 11 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, Malaysia. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Vulvovaginal symptoms of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via Vulvovaginal Symptoms Questionnaire (VSQ) (time frame: 4-weeks). 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 Jul 2026.