Postbiotic as Adjunct Treatment for Vaginal Candidiasis (NCT06474247) | Clinical Trial Compass
CompletedPhase 2/3
Postbiotic as Adjunct Treatment for Vaginal Candidiasis
India, Malaysia99 participantsStarted 2024-06-02
Plain-language 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.
Who can participate
Age range
18 Years – 81 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* 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
Exclusion criteria
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a postbiotic as an add-on treatment alongside standard antifungal therapy for vaginal candidiasis — can you tell me whether the results showed any meaningful difference in symptom relief compared to the placebo group, and whether that might be relevant to my situation?
2Since this was a Phase 2/3 trial, what does that mean for how confident we can be in the safety and effectiveness of using a postbiotic alongside my treatment, and is there enough evidence yet to consider it a standard option?
3The trial measured symptom improvement using something called the Vulvovaginal Symptoms Questionnaire — what kinds of symptoms does that cover, and do my current symptoms match what was being studied here?
4Would adding a postbiotic to my antifungal treatment actually make sense for me, or is standard antifungal therapy alone likely to be enough to resolve my infection?
5Since this trial is now completed, has the data been published anywhere, and is there anything in the findings you think I should know before deciding whether a postbiotic is worth trying alongside my prescribed treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vulvovaginal symptoms of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via Vulvovaginal Symptoms Questionnaire (VSQ)