Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis
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.
研究概览
详细说明
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
Participation in the study will be proposed to patients attending the Gynecology outpatient clinics of Torrevieja University Hospital with a clinical suspicion, in the investigator's judgment, of vulvovaginal candidiasis (VVC). The investigator will provide them with the patient information sheet so that potential participants can understand the study procedures and objectives after carefully reading it, as well as ask any questions that may arise.
If the participant expresses interest in taking part in the study, she will be given two copies of the informed consent form to complete and sign, so that her willingness to participate in the study is duly documented.
After this, all inclusion and exclusion criteria will be checked one by one, so that the volunteer may ultimately participate in the study if all inclusion criteria and none of the exclusion criteria are met. At that point, she will be assigned a clinical trial participant number in order of inclusion, by which she will be identified.
The following data will be collected in the Case Report Form (CRF):
- Demographic data: age, BMI, concomitant diseases, and usual pharmacological treatments.
- Clinical characteristics of the VVC episode: predominant symptoms, severity of the clinical condition, and prescribed antifungal treatment.
- Relevant gynecological history and VVC risk factors.
The clinical variables under study will be collected:
- Presence or absence (yes/no) of the usual symptoms associated with VVC: Abnormal vaginal discharge Pruritus Burning sensation Irritation Dyspareunia
- Vaginitis Symptom Score (VSS)
- In addition, vaginal pH will be measured using a pH indicator strip applied to the vaginal mucosa.
- A vaginal sample will also be collected for microbiological culture of Candida and culture for semiquantitative assessment of Lactobacillus.
The vaginal sample will be collected using a sterile swab. The swab will be rubbed and rotated over the vaginal mucosa to obtain secretion. The collected sample will be placed in the transport medium indicated by the center's laboratory, appropriately labeled, and sent for microbiological culture of Candida and Lactobacillus following the laboratory's standard procedures.
According to the randomization list, participants will be assigned to either the treatment group or the control group. Randomization will be performed in patients with clinical suspicion of VVC, although microbiological confirmation by culture will be carried out after inclusion.
Participants assigned to the treatment group will be provided with a bottle containing 30 capsules of the probiotic supplement Bioithas WOMAN®, which they will add to the antifungal treatment prescribed at the visit, whereas participants in the control group will receive only the antifungal treatment.
Visit 2 (V2) - End of study
As in Visit 1, the clinical variables under study will be collected:
- Presence or absence of the usual symptoms associated with vaginitis
- Vaginitis Symptom Score (VSS)
In addition, the following will be performed:
- Vaginal pH measurement
- Vaginal sample for microbiological culture of Candida and culture for semiquantitative assessment of Lactobacillus
Additionally, concomitant treatments and relevant observations during the follow-up period will be recorded, as well as any reported adverse events.
For participants in the probiotic group, treatment adherence will be assessed by counting the remaining capsules.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Juan Gabriel Agüera Santos
- 电话号码：623 02 25 86
- 邮箱：juan.aguera@bioithas.com
研究联系人备份
- 姓名：Vicente Navarro López
- 邮箱：vicente.navarrro@bioithas.com
学习地点
-
-
Alicante
-
Torrevieja、Alicante、西班牙、03186
- 招聘中
- Hospital Universitario de Torrevieja
-
接触：
- Ana María Navarro Fenoll
- 电话号码：608 33 07 27
- 邮箱：navarro_anafen@gva.es
-
接触：
- Eduardo Cazorla Amorós
- 邮箱：cazorla_edu@gva.es
-
首席研究员：
- Eduardo Cazorla Amorós, MD
-
副研究员：
- Duska Beric, MD
-
副研究员：
- Elisa Peñalver Escolano, MD
-
副研究员：
- Ana María Navarro Fenoll, SN
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：控制组
|
|
|
实验性的：Bioithas WOMAN®
|
≥1 × 10⁹ CFU of a probiotic blend composed of Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, and Kluyveromyces marxianus
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in the number and percentage of patients with complete absence of symptoms associated with VVC at the end of the 4-week treatment period between the study groups, compared with the baseline visit.
大体时间：4 weeks
|
The complete absence of symptoms associated with VVC will be assessed.
The symptoms evaluated will include: abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia
|
4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in the number and percentage of patients with absence of each individual symptom associated with VVC at the end of the 4-week treatment period between the study groups, compared with the baseline visit.
大体时间：4 weeks
|
The absence of each symptom associated with VVC will be assessed separately.
The symptoms evaluated will include: abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia
|
4 weeks
|
|
Changes in the Vaginitis Symptom Score (VSS) at the end of the 4-week intervention period between the study groups, compared with the baseline visit
大体时间：4 weeks
|
Vaginistis Symptom Score (VSS) is a clinical scale used to assess the presence and severity of symptoms associated with vulvovaginal candidiasis, based on the assessment of the main symptoms reported by the patient. The VSS includes the evaluation of the following symptoms: Abnormal vaginal discharge Vaginal pruritus Burning sensation Vaginal irritation Dyspareunia Each symptom is scored individually according to its intensity, using an ordinal severity scale, usually defined as: 0 = Absent
The total VSS score is obtained as the sum of the individual scores for each symptom, resulting in a total range from 0 to 15 points, where higher values indicate greater severity of vaginal symptoms. |
4 weeks
|
|
Difference in the number and percentage of patients with a negative vaginal culture for Candida at the end of the 4-week treatment period between the study groups, compared with those with an initially positive culture at the baseline visit
大体时间：4 weeks
|
Among patients in whom the diagnosis of vulvovaginal candidiasis is microbiologically confirmed by a positive Candida culture result, a follow-up culture will be performed at 4 weeks to assess culture negativization after the administered treatment
|
4 weeks
|
|
Adherence to the investigational product based on the count of capsules returned at the end of the treatment period among participants in the probiotic group
大体时间：4 weeks
|
For participants in the probiotic group, the remaining treatment will be collected to assess adherence during the treatment period
|
4 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number and severity of total adverse events reported by patients during the 4-week treatment period
大体时间：4 weeks
|
All adverse events occurring during the study follow-up period will be collected
|
4 weeks
|
|
Number and severity of adverse events potentially attributable to the study product during the 4-week treatment period
大体时间：4 weeks
|
Adverse events potentially attributable to the study product will be collected during the follow-up period, especially those of a digestive nature
|
4 weeks
|
|
Changes in vaginal pH at the end of the 4-week intervention period between the study groups, compared with the baseline visit
大体时间：4 weeks
|
Vaginal pH will be measured using an indicator strip at the beginning and end of the study, with the aim of assessing possible changes after 4 weeks of follow-up
|
4 weeks
|
|
Changes in the vaginal load of Lactobacillus spp. at the end of the 4-week treatment period between the study groups, compared with the baseline visit.
大体时间：4 weeks
|
Changes in the vaginal load of Lactobacillus spp.
will be assessed by semiquantitative colony count (CFU) obtained through microbiological culture on selective medium
|
4 weeks
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CVV.PROB
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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