Use of oral postbiotic as adjunct treatment for vaginal candidiasis in women
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in vaginal Candida (yeast) profile
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in vaginal Candida (yeast) profile
时间窗: at Week 0,1,2,3,4
Measured by qPCR from high vaginal swab.
时间窗: at Week 0,1,2,3,4
Change in vaginal microbiota (bacterial) profile
时间窗: at Week 0,1,2,3,4
Measured by Next-Generation Sequencing (NGS).
时间窗: at Week 0,1,2,3,4
Clinical symptom improvement
时间窗: at Week 0,1,2,3,4
Measured through validated clinical questionnaires:
时间窗: at Week 0,1,2,3,4
Vaginal Assessment Scale (VAS)
时间窗: at Week 0,1,2,3,4
Vulvar Assessment Scale (VuAS)
时间窗: at Week 0,1,2,3,4
Quality of life improvement
时间窗: at Week 0,1,2,3,4
Measured using Vulvovaginal Symptom Questionnaire (VSQ).
时间窗: at Week 0,1,2,3,4
次要结局
- Differences in clinical symptoms by VAS, VuAS(Differences in vaginal Candida levels by qPCR)
研究者
Dr Sumita Bhatia
National Institute of Paramedical Sciences