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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

India1 site
  • Sumita Hospital

    Lucknow, Aliganj, 226024

Other trials in India

Malaysia1 site
  • AIMST University

    Bedong, Kedah

Other trials in Malaysia

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.

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 groups in NCT06474247
Study groupRoleWhat they receive
PostbioticExperimentalPostbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks
Receives: Device: Postbiotic
PlaceboPlacebo comparatorPlacebo 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted25 Jun 2024
  2. Study start2 Jun 2024
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

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)
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

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.

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