Using postbiotic treatment for vaginal candidiasis
Use of Postbiotic as Adjunct Treatment for Vaginal Candidiasis in Women
This study is testing if a new postbiotic treatment can help women with vaginal candidiasis feel better when used alongside a placebo for four weeks.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 81 Years |
| Sex | Female |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 2 sites (Lucknow, Aliganj and 1 other locations) |
| Trial ID | NCT06474247 on ClinicalTrials.gov |
What this trial studies
This project investigates the effectiveness of intravaginal postbiotic administration at a dosage of 1g/day as an adjunct treatment for vaginal candidiasis in women over a 4-week period, comparing it to a placebo. Probiotics and postbiotics are known for their health benefits, with postbiotics being inactivated probiotics or their metabolites that can enhance the immune response without the risk of allergic reactions. The study aims to address the high prevalence of vaginal candidiasis, which affects a significant number of women globally, by potentially providing a new treatment option that is both effective and safe.
Who should consider this trial
Good fit: Ideal candidates for this study are sexually active women diagnosed with vaginal candidiasis.
Not a fit: Patients who are pregnant, postmenopausal, or have undergone certain gynecological surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for women suffering from vaginal candidiasis.
How similar studies have performed: Other studies have shown promise in using probiotics for vaginal health, but the specific use of postbiotics in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lucknow, Aliganj and 1 other locations
- Sumita Hospital — Lucknow, Aliganj, India (Recruiting)
- AIMST University — Bedong, Kedah, Malaysia (Not_yet_recruiting)
Study contacts
- Principal investigator: Sumita Bhatia, MD — Sumita Hospital
- Study coordinator: Sumita Bhatia, MD
- Email: bhatiadrsumita@gmail.com
- Phone: 91923569755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.