CTRI/2024/07/071175招募中4 期
A randomized, triple blinded, placebo controlled, parallel-group study to assess the effect of a multi-strain probiotic on the risk of recurrence and severity of symptoms in females with recurrent vulvovaginal candidiasis (R-VVC)
Dr Malwina Naghibi12 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年8月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 12
- 主要终点
- To compare the efficacy of the Investigational Product (IP) on incidence of culture-confirmed VVC recurrence (VVC recurrence defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days) as compared to placebo.
研究概览
简要总结
The present study is a randomized, placebo-controlled, triple-blind clinical study. 158 individuals will be screened, and considering a screening failure rate of 20 percent, approximately 126 participants will be randomized in a ratio of 1 is to 1 ratio to receive either a multi-strain probiotic or placebo and will be assigned a unique randomization code. Each group will have at least 54 completed participants after accounting for a dropout/withdrawal rate of 15 percent The intervention duration for all the study participants is 180 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Premenopausal women aged 18-50 years 2.Women with a culture-confirmed active episode caused by Candida spp.
- •(albicans or non-albicans) reported within 24-48 hours of evidence of clinical symptoms.
- •(No medications should have been initiated before the sample for culture is collected) 3.Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture per clinical diagnosis 4.Culture growth of Candida spp.
- •causing VVC 5.Random Capillary Blood Glucose of less than 110mg per dl.
- •6.Willingness to consume the study products for the entire study duration.
- •7.Willing to complete all study procedures and comply with study requirements.
- •8.Willing to abstain from other supplements or medication.
- •9.Ready to give voluntary, written, informed consent to participate in the study.
排除标准
- •1.Post-menopausal and peri-menopausal women.
- •2.Pregnant/breast-feeding women.
- •3.Use of oral or vaginal anti-fungal medication in the last 14 days.
- •4.Vaginal culture suggestive of bacterial vaginosis (Nugent’s score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
- •5.Participants found positive for Clotrimazole resistance by vaginal culture & sensitivity at screening.
- •6.Known history of allergy to Clotrimazole.
- •7.Women not willing to use any form of vaginal medication during the study.
- •8.Use of vaginal douching.
- •9.Unwillingness to use an appropriate method of contraception.
- •10.Diagnosed with compromised immune system, diabetes, or malignancies.
- •11.Use of Corticosteroids therapy in the last 30 days.
- •13.Known allergy to the study products or azoles.
- •14.Individuals with a history of frequent infections requiring antibiotic treatments.
- •16.Women who, in the opinion of the Investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the study.
- •17.Women with uncontrolled hypertension with systolic blood pressure more than equal to 140 mm Hg and or diastolic blood pressure more than equal to 90 mm Hg. 18.Heavy alcohol drinkers defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks per week.
- •For women, consuming more than 3 drinks on any day or more than 7 drinks per week.
- •19.Smokers 20.History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the Investigator, would interfere with the participant ability provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the individual at undue risk.
- •21.Presence of unstable, acutely symptomatic, or life-limiting illness.
- •22.Use of any supplements (includes probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplements, vitamins with probiotics) in the last 30 days.
结局指标
主要结局
To compare the efficacy of the Investigational Product (IP) on incidence of culture-confirmed VVC recurrence (VVC recurrence defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days) as compared to placebo.
时间窗: Day 180
次要结局
- To compare Efficacy of the Investigational Product (IP) on Changes in vaginal health as assessed by vaginal pH as compared to baseline and placebo(day 0, day 90, day 180)
- To compare Efficacy of the Investigational Product (IP) on incidence of culture-confirmed VVC recurrence (VVC recurrence defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days) as compared to placebo(Day 90)
- To compare Efficacy of the Investigational Product (IP) on Time taken to first recurrence of VVC episode from baseline between IP and placebo groups(day 0 to first VVC recurrence)
- To compare Efficacy of the Investigational Product (IP) on Number of days with VVC episode between IP and placebo groups(during the vulvovaginal candidiasis episodes, till day 180)
- To compare Efficacy of the Investigational Product (IP) on incidence of Severity of VVC episodes as assessed by symptoms (itching/soreness, edema, dysuria, vaginal discharge, dyspareunia, erythema, fissures/excoriations) severity on a 4-point Likert Scale as compared to baseline and placebo(during episodes)
- To compare Efficacy of the Investigational Product (IP) on Proportion of C. albicans positive VVC episodes vs other pathogens(during episodes)
- Number of administrations of To compare Efficacy of the Investigational Product (IP) on vaginal pessaries during acute episodes as compared to baseline and placebo(during episodes)
- To compare Efficacy of the Investigational Product (IP) on Changes in vaginal microbiology as assessed by vaginal Candida albicans culture as compared to baseline and placebo(during episodes)
- To compare Efficacy of the Investigational Product (IP) on Quality of life as assessed using SF-36 as compared to baseline and placebo(day 0, day 90, day 180)
- Exploratory endpoint:Influence of IP on vaginal microbiome in R-VVC as assessed by Shotgun analysis on vaginal swab sample(day 0, day 90 & day 180))
研究者
Dr.Sajay Vaze
Vedic Lifesciences Pvt. Ltd.
研究点 (12)
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