Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Bioithas SL
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Open-label, randomized clinical trial with a control group and a 4-week intervention period. The study will evaluate the efficacy of the probiotic supplement Bioithas WOMAN® as an adjunctive treatment in women with clinically suspected vulvovaginal candidiasis (VVC).
All participants will receive the antifungal treatment prescribed by the investigator. Participants allocated to the probiotic group will additionally receive Bioithas WOMAN®, supplied as a bottle containing 30 capsules, to be taken during the 4-week intervention period.
The study includes two on-site visits: Visit 1 (baseline) and Visit 2 (week 4/end of study). At baseline, demographic data, relevant gynecological history, VVC risk factors, clinical characteristics of the current episode, concomitant diseases, and usual pharmacological treatments will be recorded. Clinical symptoms associated with VVC, including abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia, will be assessed, together with the Vaginitis Symptom Score (VSS).
At both visits, vaginal pH will be measured using an indicator strip applied to the vaginal mucosa. A vaginal sample will also be collected using a sterile swab for microbiological culture of Candida and semiquantitative assessment of Lactobacillus. Although randomization will be performed in women with clinical suspicion of VVC, microbiological confirmation by culture will be obtained after inclusion.
At the final visit, the same clinical and microbiological variables will be reassessed. Concomitant treatments, relevant follow-up observations, and any adverse events reported during the study will also be recorded. In the probiotic group, adherence to treatment will be assessed by counting the remaining capsules.
详细描述
Open-label, randomized clinical trial with a control group and a 4-week intervention period.
During the study, 2 on-site visits will be carried out:
Visit 1 (V1) - Study start: Inclusion of cases and controls Visit 2 (V2) - End of study: Week 4 of treatment and follow-up
The procedures performed at each visit are described below:
Visit 1 (V1) - Study start
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of reproductive age who use effective contraceptive methods during the course of the study.
- •Clinical suspicion of vulvovaginal candidiasis, in the investigator's judgment, based on the presence of symptoms - e.g., pruritus, burning sensation, irritation, dyspareunia and/or abnormal vaginal discharge - and/or compatible clinical findings.
- •Possibility of collecting a vaginal sample at the baseline visit for microbiological analysis.
- •Ability and willingness to comply with the study procedures and to sign the informed consent form
排除标准
- •Menstruation at the time of inclusion.
- •Pregnancy or breastfeeding.
- •Menopause or perimenopause.
- •Diabetes mellitus.
- •Presence of immunocompromised status or treatment with immunosuppressants within the 3 months prior to inclusion in the trial.
- •Vaginal coinfection in addition to vulvovaginal candidiasis.
- •Severe chronic diseases or other active infections that may interfere with the clinical assessment of vulvovaginal candidiasis, in the investigator's judgment.
- •History of intolerance or hypersensitivity to the intervention products.
- •Treatment with antifungals or probiotic supplements in the month prior to inclusion in the trial.