Use of oral postbiotic as adjunct treatment for vaginal candidiasis in women
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Change in vaginal Candida (yeast) profile
Study Overview
Brief Summary
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of an oral postbiotic (0.5 g/day) as an adjunct treatment for vaginal candidiasis in women. A total of 118 sexually active women with clinically confirmed vaginal candidiasis will be enrolled and randomized in a 1:1 ratio to receive either the postbiotic or a placebo for 4 weeks. Prior to randomization, all participants will receive standard antifungal therapy with a 3-day clotrimazole vaginal suppository.
Participants will be assessed weekly for clinical symptoms, quality of life, and changes in vaginal microbiota. High vaginal swabs will be collected at baseline and weekly to evaluate Candida levels, bacterial profiles, protein concentrations, and immune gene expression using qPCR and next-generation sequencing. The study seeks to determine whether oral postbiotics can enhance symptom improvement, support vaginal microbiota balance, and reduce recurrence risk when used as an adjunct to standard antifungal treatment.
The results are expected to generate important evidence on the potential benefits of postbiotics in managing vaginal candidiasis and improving women’s vaginal health and overall well-being.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
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.
Outcomes
Primary Outcomes
Change in vaginal Candida (yeast) profile
Time Frame: at Week 0,1,2,3,4
Measured by qPCR from high vaginal swab.
Time Frame: at Week 0,1,2,3,4
Change in vaginal microbiota (bacterial) profile
Time Frame: at Week 0,1,2,3,4
Measured by Next-Generation Sequencing (NGS).
Time Frame: at Week 0,1,2,3,4
Clinical symptom improvement
Time Frame: at Week 0,1,2,3,4
Measured through validated clinical questionnaires:
Time Frame: at Week 0,1,2,3,4
Vaginal Assessment Scale (VAS)
Time Frame: at Week 0,1,2,3,4
Vulvar Assessment Scale (VuAS)
Time Frame: at Week 0,1,2,3,4
Quality of life improvement
Time Frame: at Week 0,1,2,3,4
Measured using Vulvovaginal Symptom Questionnaire (VSQ).
Time Frame: at Week 0,1,2,3,4
Secondary Outcomes
- Differences in clinical symptoms by VAS, VuAS(Differences in vaginal Candida levels by qPCR)
Investigators
Dr Sumita Bhatia
National Institute of Paramedical Sciences